Proceedings of the Standing Senate Committee on
Social Affairs, Science and Technology
Issue 4 - Evidence - June 4, 2009
OTTAWA, Thursday June 4, 2009
The Standing Senate Committee on Social Affairs, Science and Technology met today at 10:45 a.m. to study 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 deal with Bill C-11, An Act to promote safety and security with respect human pathogens and toxins.
This will be the first of two meetings we have scheduled on the subject. Today, we will hear from government officials as well as an associate professor at Dalhousie University. Next week, we have tentatively set Wednesday's session to hear from some who have concerns about the bill, some who may be making suggestions for changes and some people who will be supporting the bill. We will have a mixture of people at the second meeting.
We can be supportive of the intent of this legislation. However, we have to look at it to determine if there are any unintended consequences, if there are things that go beyond or do not address sufficiently the objectives of the bill. We are here for sober second thought, as they say.
To begin, we have three officials. First, we have Dr. David Butler-Jones, Chief Public Health Officer, Public Health Agency of Canada. He is no stranger to this committee. We also have Dr. Theresa Tam, Director General, Public Health Agency of Canada; and Irit Weiser, Senior General Counsel, Head of Legal Services, Health Canada. As I mentioned, later on we will have Elaine Gibson, Associate Professor, Health Law Institute, Dalhousie University.
Dr. Butler-Jones, we will start with you.
Dr. David Butler-Jones, Chief Public Health Officer, Public Health Agency of Canada: I am pleased to appear before the Standing Senate Committee on Social Affairs, Science and Technology to discuss Bill C-11, An Act to promote safety and security with respect human pathogens and toxins.
[Translation]
Bill C-11 is an important piece of legislation that will enhance safety and security in Canada by filling an existing gap in Canada's regime with regard to human pathogens and toxins.
[English]
I must say this committee has been instrumental in defining appropriate federal involvement in addressing public health issues. Of many, I would like to acknowledge the 2003 report entitled, Reforming Health Protection and Promotion in Canada: Time to Act, when the committee was chaired by Senator Kirby and co-chaired by Senator LeBreton. I would also like to recognize the subcommittee report on population health that was tabled yesterday by Senator Keon and Senator Pépin.
The report on health protection and promotion was instrumental in recommending the creation of the Public Health Agency of Canada and in illustrating the need for appropriate federal oversight and ability to respond to public health threats. Since its creation in 2004, the Public Health Agency of Canada continues to make progress in building a cohesive set of programs and activities that have become an effective and unified federal entity charged with protecting and promoting public health.
Today, six years after the SARS crisis that triggered this committee's report and in consideration of the recent H1N1 flu virus outbreak, there is clear recognition of the role played by the Public Health Agency of Canada in improving and protecting the health of Canadians.
[Translation]
Along with the creation of the agency itself, Bill C-11 is another step toward ensuring appropriate measures are in place to limit health and safety risks to Canadians.
[English]
Under existing federal regulations with respect to human pathogens and toxins, only those who import those agents are currently required to comply with the Laboratory Biosafety Guidelines, which are the national standard for biosafety in Canada. There are no mandatory federal safety requirements for laboratories working with agents that are not imported. This means approximately half of the laboratories in Canada who work with human pathogens or toxins are not obligated to follow national biosafety guidelines. This stands in stark contrast to the approximately 3,500 other such facilities that work essentially with the same agents but which have already had to follow the Laboratory Biosafety Guidelines for 15 years under the existing Human Pathogens Importation Regulations.
We face unnecessary risks due to this legislative gap. These risks apply to those working in these unregulated laboratories and to the public's health at large.
Currently, no one knows for certain who has access to which dangerous human pathogens or toxins in Canada, or where these materials are. An additional concern is that no data is now being collected on a national basis regarding laboratory-acquired infections. This represents a serious safety and security gap that we must address.
University and provincial laboratories in Canada do a great job of ensuring their students and staff are using appropriate biosafety protocols. However, there are many other laboratories that may house dangerous agents like listeria, salmonella and others, for which there are no requirements to follow Laboratory Biosafety Guidelines, because these agents are not imported.
There are no consistent requirements to ensure the appropriate biosafety guidelines are used in these laboratories. This is unacceptable. Perhaps even more serious is the fact that persons accessing and assessing the most dangerous agents do not have to undergo mandatory security screening.
[Translation]
Clearly these risks need to be dealt with.
[English]
Bill C-11 would require that persons with access to the most dangerous human pathogens — those in Risk Groups 3 and 4 — and select toxins are appropriately security screened. This is already the case in federal laboratories and should be the norm elsewhere.
The intention of Bill C-11 is not to increase the regulatory burden. In fact, for most laboratories that are generally compliant with the Laboratory Biosafety Guidelines under the existing Human Pathogens Importations Regulations, there should be little impact from this bill. Due diligence will be required of every person working with human pathogens or toxins, according to the duty of care provision found in clause 6. Bill C-11 will also allow us to track who has these human pathogens and toxins, and help us respond and work with our international health partners when there is a problem.
Stakeholders, as well as provinces and territories, were consulted prior to the drafting of the Human Pathogens and Toxins Act and their input is reflected in Bill C-11.
Further input received from the provinces and territories and stakeholders before the House of Commons Standing Committee on Health led to 12 prudent amendments to the bill in the House of Commons. The effect of the amendments was to make this a stronger and more transparent piece of legislation. The changes accord with the policy intent behind the bill and our plans, and directly address numerous stakeholders concerns. A spirit of cooperation emerged in the House of Commons regarding these amendments, which reflected the need to move forward with this important legislation.
As we move ahead with this legislation and subsequent regulations, we will be balancing the needs of science and research with the need to enhance our safety and security.
To achieve this balance, the Public Health Agency of Canada will conduct wide-ranging consultations on the development of the program and the regulatory framework for Bill C-11.
[Translation]
Stakeholder input is crucial to the success of this initiative. We look forward to continuing this dialogue and moving forward.
[English]
I urge you to support this legislation and I look forward to answering your questions.
The Chair: Will either of the two beside you make opening statements?
Irit Weiser, Senior General Counsel, Head of Legal Services, Health Canada: No, we are here for questions.
The Chair: There were a couple of things that came out of the testimony before the House of Commons Standing Committee on Health that I want to follow up on. One was that there is an indication that it might be five years before the regulations are in effect for this bill. Is that true? If so, what happens in the interim period before the regulations are ready?
Second, some of the concerns that have been expressed have been with respect to Risk Group 2 — the procedures that may have some unintended consequences. I think we will hear from some people next week about that. As I understand it, the Health Committee heard evidence that there would not be a requirement for a licence with respect to Risk Group 2. Instead, only registration would be required.
Could you clarify that and also tell us what the difference is in terms of the procedures to be followed and the administrative burden with respect to the difference between licensing and registration?
Dr. Butler-Jones: Thank you very much for the question. I will speak briefly to it and then I will turn it over to Dr. Tam, who will speak more to the specifics.
It will take time to get the regulations. We want to ensure there is appropriate and extensive consultation to do so and provide time to comply. At the same time, once the bill is proclaimed, then we will be seeking lists from laboratories so we will know what laboratories in the country actually have which pathogens. Therefore, should there be an event, we have that ability in place. As I say, half the labs are already in compliance with that because of their work with imported pathogens.
Second, in terms of the issue of Risk Group 2, we have had a number of events that would fall under Risk Group 2. There was a mini-pandemic in the 1970s of an H1N1 strain — a different strain to the one we have now — which has given rise to circulating strains since. It has not given rise to the new strain, but appears to have come from a lab, initially, which then led to thousands and millions people around the world affected.
We also had an event in the early days of the agency where, for lab proficiency testing purposes, an H2N2, which was the last pandemic of the 1960s and for which no one born since the 1960s has any immunity, was circulated around the world as a lab proficiency test. In other words, they sent it out to the labs to test to ensure they coulf find influenza. It is part of the accreditation of laboratories, which included doctors' offices that do this kind of testing in their back corner.
However, it was sent out by mistake, as an H2N2. Normally you would send out an H3N2, one of the circulating viruses of the time, which does not pose an additional threat. However, having sent out the H2N2, we were able to track it down quickly because it was an import, because we had the regulations, because we knew who had it and we knew where it came from. That allowed us to engage our partners in the U.S. and WHO to contact and engage labs around the world to eliminate this virus, which could have been the next pandemic and could have been more than embarrassing for our American cousins.
With that, I will turn it over to Dr. Tam for some additional information.
Dr. Theresa Tam, Director General, Public Health Agency of Canada: In terms of the implementation of the new legislative framework, it will be done in three phases. Upon Royal Assent there will be certain prohibitions coming into play immediately. One of them is banning of activities with certain human pathogens, specifically at this point in time, smallpox. No one should be working with smallpox.
The second prohibition that comes into force upon Royal Assent is prohibiting intentionally releasing human pathogens or toxins that would cause risk to health and safety.
Third is failure to take reasonable precautions, which is the duty of care when someone is knowingly dealing with human pathogen toxins.
The first phase upon Royal Assent will also require that persons responsible for activities involving human pathogen toxins provide us with basic information. Within 90 days, all who work with these pathogens should provide to the Public Health Agency of Canada their name and contact information, and basic information as to what type of pathogens they are currently working with, whether they are working with risk groups 2, 3, or 4 pathogens. That is basic information and does not bring into force the licensure requirements at that stage.
We would then know the full extent of the laboratories that do not currently come under the human pathogens importation regulations. That serves also as a mechanism for us to communicate with these laboratories.
In phase 2, which will take an unpredictable period of time, we will develop the program and regulatory framework. We estimate that, with extensive consultations and the drafting of the regulations and other policy pieces, this may take upwards of two years.
Then in phase 3, we wanted to provide a period of time for people to become compliant. At that point, because there is a range of mandatory requirements that would include the necessity to obtain a licence and report on inventories, we will be consulting with the stakeholders as to what is a reasonable period of time for them to get ready and to bring things into force. We do not know if it is five years, but it will be a number of years before that third phase will come into force.
The Human Pathogens Importations Regulations will continue to apply during this period until they are repealed in the third phase so there are not any gaps left with the current regulatory system.
In terms of risk group 2 pathogens, Dr. Butler-Jones emphasized why they are dangerous and why it is important to bring them into the scope of the bill. It is always the program intent that we treat these pathogens according to their variable levels of risk. That risk group 2 human pathogens will be treated differently in the facilities that handle them. That they are treated less stringently has always been the program intent.
There were a number of amendments to the bill when it went through the House of Commons to clarify the original program intent. This includes removing security clearance for persons accessing risk group 2 pathogens so it is more explicit in the legislation itself. As well, they provided that the Governor-in-Council must consider the varying risks inherent in these different risk groups with human pathogens when making regulations. So we will be treating risk group 2, because there is less risk, using less stringent regulatory requirements. The amendments also clarified matters by reducing possible penalties regarding contraventions of the act and regulations with risk group 2 human pathogens. We heard the stakeholders indicate their discomfort with leaving everything in the regulations, and have tried through these amendments to bring further clarity to some of those concerns.
Laboratories working with risk group 2 pathogens will be brought into the licensing scheme in the third stage. We, at this point, have no intention of not requiring licences. However, there are varying requirement, including, for example, inventories. For risk group 2, it may be a process of self-registration of what type of pathogens they have. So, and inventory requirements and bio-safety office requirements may be less stringent.
The question you had requiring licensure, there was no intent not to have licensure. The intent was still to require licensure for this range of laboratories.
Dr. Butler-Jones: The implications will clearly be different in terms of what is involved in the licence and what is required if all you have is level 2 pathogens. It is in the regulations because all pathogens, even within a group, are not the same. The risk of certain level 3 pathogens is not as much in terms of public health, or the laboratory issues, as others. Therefore you do not want to treat all level 2s and level 3s the same, and part of the consultations will be about what bugs fit where. Because our understanding changes over time, the science changes over time, the requirement of what level of care you need does change and that is why its in the regulations rather than legislation.
For example, if you just specify H1N1, a form of H1N1 is circulating in the community as part of our regular vaccines. The new H1N1 is totally different and it looks like we are heading into the pandemic. In that situation, you want to at least initially treat that bug differently from the normal H1N1, and regulation or policy allows you to do that where legislation is more difficult.
Senator Segal: Before beginning with a few questions, I wanted as a citizen to express my appreciation to Dr. Butler- Jones for the work that he and the Public Health Agency of Canada have done on the H1N1 issue. There has been remarkable clarity and communication to the public. I believe it has helped Canadians coming to terms with both their obligations and their day-to-day responsibilities in terms of personal hygiene that I am sure has been constructive. God knows our public servants are subjected to enough unfair criticism. Even on occasion when it is a bit justified we should take a moment to give a word of praise and thanks when they perform extremely well under difficult circumstances. I am delighted to express that to you and I know I speak for millions of Canadians in so doing.
With respect to the legislation, I have four questions and they are brief.
The first one: Is it now not illegal to release some of these pathogens? I think Dr. Tam made the reference to making it illegal to release pathogens. I assume it is now illegal to release many of these pathogens.
Second, I take the position that lab technicians, scientists, doctors and researchers are citizens. They have rights. They have rights to be protected from unfair search and seizure. They have rights to be presumed innocent rather than assumed to be guilty of an offence under this proposed legislation. I would like some advice from counsel or yourself, Dr. Butler-Jones, with respect to the advice you received from the Department of Justice that section 41 of the proposed act, which is quite arbitrary, is compliant with the Charter of Rights and Freedoms, and whether counsel might be prepared to share that advice with this committee.
I am sure the intent is to have it comply with the Charter of Rights and Freedoms, but I think there may be issues. It would be most constructive if you could share that with us.
I then wanted to ask about the difference between prophylactic legislation to keep bad things from happening, which is what I believe this legislation is about, and legislation that responds to some incidents in the marketplace indicating that there is a serious problem that needs correction. If there has been a serious problem in the past, other than the few areas of lab error, which you have been kind enough to reference both in the States and elsewhere, could you share with us what that database is or how we should judge it? If there is not, do you not worry that this may be a piece of legislation, and this often happens, drawn up for purposes which are now compelling, but which produces some adverse outcomes in the future, as our chairman referenced, which are actually contrary to the public interest in some respects?
To give you an example, if, God forbid, we needed to look at a new pathogen on an urgent basis and distinguished scientific advice said there is an outstanding chemist or researcher in Japan we need here now to help us with this, would we be sorting out a security clearance for that purpose when minutes and hours and days may be of vital importance? It is also not clear to me from the legislation, and perhaps I have not read it carefully enough, who grants the security clearance. Is it the normal RCMP, CSIS, CRA kind of questions asked of people who need to have security clearance or is there some special process related to pathogens which is anticipated in the bill? Let me leave it at that because others have questions.
Dr. Butler-Jones: Thank you, senator. We will see if I can get through all your questions and I will pass supplement comments on to Dr. Tam and to counsel.
First, this is less about intentional release than it is about understanding what is out there and where it is. Intentional release is uncommon and, in effect, a terrorist act, for which there are other provisions.
This legislation ensures that the appropriate bio-safety is in place for all labs in Canada that are handling dangerous human pathogens and toxins. It is already in place for those who import and export, which is probably about half the labs. It is not in place for the others, and we just do not know what is there. The security issue is, first, that we do not know and, second, that there is no assurance that basic bio-safety is being followed.
It should not be a challenge for university and other high quality labs. We hope it will be easy for others to comply, but we just do not have an answer to that. In that sense, it is prophylactic. Because we do not know what we do not know, the potential risk there is high.
We have seen, for example, labs abandoned with fridges full of bugs and nobody knows what is in there. People have taken off and then what do you do? You do not know where it has been sent or what has been done with it and not for any nefarious purpose but simply by neglect or lack of understanding.
We now have 15 years of experience with the import/export regulations and the licensing around that. We have not had an issue with those labs. Where there has been a concern, it has been addressed because we have the expertise working with them to actually address it. All of these labs want to do that. This will allow us the opportunity for all labs dealing with these pathogens to have access to that expertise to ensure they are following the regulations both for the sake of their own staff but also for public health purposes.
Dr. Tam will speak to the security clearance more specifically, but one of the things we have been working on over the last four or five years is an international approach to issues, which is telling and really showed in the H1N1 event. We were doing lab testing for the Mexicans; we were working closely with the Americans and the Mexicans; we were able to identify what the virus was in Mexico and share that with WHO and the Americans and our other colleagues. If we need a scientist in an instant, we can call up that lab in Japan and say, ``Can you do this for us,'' and that is the way we have worked over the last few years and I think it stood us in good stead for H1N1 and will do so in the future.
I do not think it is a concern in that sense and in that scenario. Obviously people are concerned about ensuring they have the expertise and are able to hire the right expertise, and Dr. Tam can speak to the variations on this. I will turn to Ms. Weiser first in terms of the legal position.
Ms. Weiser: Thank you. If I understand the nature of your question properly, it was concerned largely about the inspection provisions in the bill.
Senator Segal: The appointment of inspectors, their ability to enter at will, seize, destroy and do a whole bunch of things without what we normally refer to as a warrant issued by a judge.
Ms. Weiser: The inspection powers contained in this bill mimic provisions in the Food and Drug Act, the Hazardous Products Act and many other federal and provincial statutes. They are an important part of statutes that regulate activities considered beneficial for Canadians, provided they are done according to the manner set out in the act and regulations.
The purpose of inspections is to ensure and encourage compliance from the regulated community and to correct processes and procedures that may expose the public to risk. By their nature, inspections are not triggered where a contravention is suspected; rather, they are intended to be routine and responsive.
The inspection provisions were reviewed from a Charter perspective by the Department of Justice quite extensively. I cannot make the opinions available by virtue of solicitor/client privilege. I would refer to Supreme Court of Canada decisions where inspections have been considered by the court from a Charter perspective, including the ability to enter the premises and the ability to look at documents. The cases I would point to are Potash and Thomson. These were again supported in recent jurisprudence in Jarvis. The Supreme Court has recognized the latitude that must be given to inspections.
If you would permit me, I would like to read a few sentences from one of the decisions. This is the Potash decision, and they were referring back to an earlier decision in Thomson Newspapers:
In a modern industrial society, it is generally accepted that many activities in which individuals can engage must nevertheless to a greater or lesser extent be regulated by the state to ensure that the individual's pursuit of his or her self-interest is compatible with the community's interest in the realization of collective goals and aspirations. In many cases, this regulation must necessarily involve the inspection of private premises or documents by agents of the state. The restaurateur's compliance with public health regulations, the employer's compliance with employment standards and safety legislation, and the developer's or homeowner's compliance with building codes or zoning regulations, can only be tested by inspection, and perhaps unannounced inspection, of their premises.
That is not to say that the court has granted the state carte blanche. The Charter requires that the actions be reasonable, and that applies all the time. The inspectors' actions must be in furtherance of the act. For example, the law does not empower them to go in and take income tax records because that is not relevant to the purposes of the act. Inspections are always in furtherance of the act.
Similarly, the Privacy Act continues to apply to all the actions of inspectors under the act, and it confirms again that their actions must be in furtherance of the act. If they take material, it is for the purposes of verifying compliance with the act. They are not given, as I said, carte blanche.
The Chair: Was the Privacy Commissioner consulted on this?
Ms. Weiser: She was consulted extensively.
The Chair: She did not express any concerns and was fine with what you did?
Ms. Weiser: The Privacy Commissioner did raise a number of concerns, which have been addressed with her. Some of the changes incorporated by the House of Commons committee were a result of the concerns raised by the Privacy Commissioner.
The Chair: If you have a further question, Senator Segal, I could put you down for a second round, unless there is something you need to clarify.
Senator Segal: They were going to answer the question on security clearance.
The Chair: Security clearance is a question that needs to be answered.
Dr. Tam: I will get straight to the point. Security requirements are for Risk Group 4 and certain Risk Group 3 pathogens. They are the most dangerous pathogens. We are intending to use normal security clearance processes and of course Privacy Act and other elements apply to that as well.
If we needed to get someone in quickly, there is a provision in the act that says you can be accompanied by someone who is security-cleared so that you are supervised. If a foreign scientist was to come into the National Microbiology Laboratory, that person must be accompanied, and I think that is reasonable.
Senator Callbeck: Dr. Butler-Jones, you mentioned in your brief that the provinces and territories were consulted. Did they raise concerns, and, if so, have those concerns been addressed?
Dr. Butler-Jones: There are two aspects to that. They did raise concerns, in the sense of the application of the law. This is, as you may know, the second time this legislation was tabled. The first time there was a series of consultations. After that, based on those consultations with academics, the provinces and territories and others, there were changes in this version of the bill. For example, they removed the specificity around security clearance and did not separate level 2 from others. That was because what came through in the consultations was a request to put all that in regulations where it is more flexible, where you can bring the science to bear, where you can adapt them as necessary, et cetera. We did that. Then, when this legislation came forward, people said it was too broad. The amendments were intended to address the concerns about the intent that would underlie it and we will continue to work with them through the development of regulations.
My understanding, because we have talked to all deputies and chief medical officers and others, is that they are comfortable with the intent and where we are headed. Ultimately, people will only be satisfied when they see not only that the regulations are in place, but how they are applied. We do have the advantage of 15 years of experience with the import-export regulations that people have been quite happy and comfortable with, so we are anticipating that that should not be an issue.
Again, it is around areas about what you are going to do and how you will do it, and that is specificity in the regulations. We will be consulting with them on the process of consultation first, to ensure that we are talking to the right people from their perspective, that we are engaging on the right questions, et cetera.
Senator Callbeck: You are going to involve the provinces in the regulations. How do you propose to inform the other stakeholders?
Dr. Butler-Jones: The same way: we have engaged other stakeholders, universities and others. I have met with university science presidents, vice-presidents and others and they have written to me. I have responded to them. They say they are comfortable with the response and our intent. The regulatory framework was helpful for them to see how we are planning to proceed. They look forward to the consultations around and the development of the regulations. That is for a range of laboratories, academics, researchers, PTs, industry, et cetera.
Senator Callbeck: You mentioned on page 4 that approximately half the laboratories in Canada are not obligated to follow the national bio-safety guidelines. What guidelines do they follow?
Dr. Butler-Jones: It depends. We do not know because we do not even know that many of them exist at this point. Some jurisdictions and provinces do have some regulations but they tend to be regulations around health and safety, and in terms of quality of testing, where they exist. They do not really address these issues we are addressing. There is a gap there that this legislation will also address, even for those jurisdictions that have some regulatory authority over laboratories.
This does not regulate the laboratories. This legislation regulates the handling of pathogens.
Senator Callbeck: You say half the laboratories. How many are there in Canada?
Dr. Butler-Jones: We are guessing that we know about half of them, or that half of them are importers and exporters. It could be larger. Again, once the act is promulgated there will be an obligation for people to report. We will then know what is out there.
Senator Callbeck: What figure does that half represent? Is it 50?
Dr. Butler-Jones: We think that there are as many laboratories out there that are not under the current regime as are under the current regime. We do not have an accurate figure because we do not know where they are.
Senator Callbeck: How many are under the current regime?
Dr. Butler-Jones: 3,500.
Senator Eaton: Can you talk about the licensing? If I am a laboratory and I have told you I am a laboratory and what pathogens I have, and I am a Risk Group 2, what will you require for me to get a licence?
Dr. Tam: The key is that much of this will come under the consultations in terms of the details and what is in the scope of licensure. For example, the licence is for people carrying on controlled activities. For Risk Group 2, we generally expect these to be relatively simple. For example, you may have to provide an online checklist and attestation of your compliance with the laboratory bio-safety guidelines. These are the basic standards that we would like to apply across the country, so they will attest to the fact that they are compliant, and they provide a checklist and application online.
They would then be carrying on controlled activities with respect to Risk Group 2 pathogens only. If they think they will be doing something else, they would have to notify the regulators. In the scope of the licence, we look at inventory requirements and that is another point where a lot of consultation is required as to what is reasonable for Risk Group 2 versus 3 and 4.
We envisage for Risk Group 2 that we need not count every vial of pathogen. We need to know that you have a certain range of pathogens and what they are. For the highest level, you do want to know the amount of Ebola virus someone has, and if a vial is accounted for. There will be varying requirements for inventory.
Security screening will not be required in Risk Group 2, but will be in the scope of Risk Groups 3 and 4. How you handle and transfer pathogens is something we look at in the licence. For example, if you are importing, we could put into the licence the importation scope of your licence. If you are transferring pathogens within Canada, that can also be looked at in terms of being in the scope of a licence as a laboratory that would transfer pathogens to others.
We would be able to build that into a laboratory. If you are applying this year, we expect that you have only these pathogens; you are handling them with the bio-safety guidelines; you will be exporting to a certain number of laboratories; you may be then importing certain pathogens into your laboratory, and that will be worked out.
We will also look at disposal of pathogens, how someone is disposing of the waste. These types of things are what we would envisage being in scope, but it will vary depending on the risk group.
Senator Eaton: You explained, Dr. Butler-Jones, that pathogens and toxins take on a life and they change according to what you do with them. Will there be a review every two or three years? H1N1 is not level 3 any more or 4; it becomes a 2; TB now is a 3 or a 4. Who will determine that?
Dr. Butler-Jones: One of the amendments to the legislation, which was actually our intent, was to have an advisory group that would review regularly what is in, what is out and how we apply it. On the issue of what is level 3 and level 2, there are actually other discussions, which is also part of why they wanted us to be more general and have it in the regulations.
Not all level 2s are the same in terms of how they are handled and what the risks are. You would not necessarily want to have a security clearance if all you are dealing with is tuberculosis, for example. There will not be security clearance for any 2s, and for 3s, you will not need security clearance for some, but for others, for example, anthrax, you probably would. A committee would review them regularly and provide scientific advice as to how we manage pathogens.
Senator Eaton: Ms. Weiser, there is a possibility of criminal charges. How did you determine what the penalties would be or should be?
Dr. Butler-Jones: Essentially, the provisions are consistent with provisions in other legislation. The intent was to be as consistent as possible. The practical issue is obviously that if someone is charged, that does not mean they are convicted or that they have a fine. There has to be a process, but with 15 years of dealing with 3,500 labs in the country, we have not ever had to resort to that.
The Chair: Can I follow that up as supplementary? What about an administrative error, where somebody might normally get fined for doing sloppy paperwork or something like that? You will now potentially make criminals of them. They may not get convicted, as you pointed out, but they might go through a harrowing experience of having to defend themselves against charges. How would you handle those?
Dr. Butler-Jones: It would be handled by discussion, not by charging. We have pretty strong legislation in public health. It is used and applied rarely. It is the last stick when you have an organization or an individual that is totally noncompliant. It is not about paperwork but because they are a threat to the public in some way. In 15 years of applying the regulations and legislation related to import, there has never, as far as I know, been a charge levied. No one has had to defend a charge because everything has been worked out through discussion and the reasonableness of it is that we expect to apply.
The Chair: Some lawyers might argue that good intent is not enough. You expose people by the law to something that could be more severe.
Dr. Butler-Jones: There are reasonable provisions in the legislation, and to fine someone thousands of dollars for a paperwork or administrative error would be unreasonable, in my view.
Ms. Weiser: The penalties were developed through consideration of the severity of the offence. For example, level 2 is treated differently from levels 3 and 4. There are also different provisions where an action is done with intent.
For example, some general offences relate to Risk Group 2, and they are dealt with by way of summary conviction, and the maximum penalty for a first offence is a fine of up to $50,000, with no imprisonment. There are more serious penalties for Risk Groups 3 and 4, and then there are some very specific offences and penalties where offences are committed intentionally, recklessly or knowingly. As Dr. Butler-Jones mentioned, these again reflect similar provisions in other regulatory-type legislation.
The criminal law power under which this bill has been developed is a power that the Supreme Court has interpreted to allow the federal government to legislate in a wide range of areas. It is not confined just to the Criminal Code. The court has told us that it is available as a head of power where there is a prohibition accompanied by a sanction and where the prohibition is based on a legitimate public purpose, which includes public health and safety. As you know, this bill is based on protection of public health and safety.
Bill C-11 is not unique in terms of public health legislation enacted under the criminal law power. I would point to the Food and Drugs Act, Hazardous Products Act, Tobacco Act and the Firearms Act, and they all have similar types of penalties.
Senator Eaton: You are saying that Risk Group 2 is mostly university and school labs. If somebody drops a vial on the floor, that is an accident. If somebody purposely goes outside and pours it down the drain, that is another problem. It does not pertain to normal lab activity. It is there in case it is needed.
Ms. Weiser: That is right.
Senator Segal: Counsel said that the courts have allowed you to use the criminal law in a broad way. Some would argue that is why we now see governments, Bill C-6 is another example, criminalizing areas of civil liability. They do it because they can rather than because it is the best way to protect the public. That is a question.
Ms. Weiser: The criminal law head of power is a basis on which the federal government can decide to enact legislation. That is all it is. It has been defined in a way by the court as requiring that there be a prohibition accompanied by a sanction and that it be for a valid criminal purpose, which includes public health and safety. We use it to address a number of matters that are important to the public, such as the authorization of drugs so that we know that they are safe. It is used to limit advertising of tobacco to try to dissuade people from taking up smoking. It is the basis on which the government can create legislation. That is what it is.
Senator Keon: The legislation itself seems straightforward to me. It has been well massaged before it got to us.
My question relates to the inventory as applied to the global community. For example, for prohibited human pathogens and toxins, how reliable is your source of information on inventory at the international level? Have you any idea what is in North Korea?
Dr. Butler-Jones: I do not have any idea what is in North Korea. It will vary depending on the countries. With like- minded countries, we will have a better sense, and this will give us a better sense than we have currently.
As a reflection, the international health regulations that came out of SARS, that preceded H1N1, are already being looked at in terms of what else needs to be part of them in the future.
One of the issues that is required of member countries is that we do not basically export problems, either people or otherwise, but the risks that are inherent in having human pathogens where you do not know who is handling them or whether they are handling them in a reasonably safe manner adds to our national liability in the international scene. That having been said, clearly some countries are not transparent, but there are also other sanctions against those countries in various ways.
Senator Keon: Are you satisfied that the global inventory that you have access to is accurate?
Dr. Butler-Jones: No. It all depends on the country in terms of what exists and what is held where. We have a good sense among — for lack of a better term — like-minded countries that we deal with commonly. Some have much better sense and control over what they have than we do.
There are a range of things we are not certain about currently in other jurisdictions, though things are changing. Development of international health regulations assisted with that. WHO's direct engagement with countries on these matters is assisting. Even our relationship with China since SARS in terms of transparency has improved dramatically. We have a member of the Public Health Agency stationed in Beijing and constantly working with the Chinese on a range of public health issues.
It is much better, but could it be better still. With time, as other countries implement the provisions that we are — and many countries already have in place — this will enhance global security generally.
Dr. Tam: From a public health perspective, we hope and think we know where the smallpox virus is. However, there is always a concern that someone left it in a freezer and they do not know about it. Smallpox was in wide circulation in the world in the past.
Polio is another example where a global effort to inventory where the virus is located is underway in areas where it has been eliminated and is undergoing eradication processes. Bill C-11 would allow us to have a much better sense of exactly where the polio virus is in Canada. That is an obligation we have internationally and, in turn, we will receive information. The WHO has good information on where the polio virus resides in the world.
The SARS virus might be another example. SARS is no longer circulating in the human population at this point. Its re-emergence can only occur in two different ways. First is that it may pop up again wherever it originally came from. Second, many labs tested for the SARS virus. Even Canada has many specimens in different laboratories. That is another virus where it would be good to know who possesses that in Canada. We would also like to know that throughout the world.
Senator Dyck: This is an important and necessary piece of legislation. I have two questions for you on the inventory and on the inspectors.
With regard to the inventory, I noticed several neuro-toxins in the list of compounds including tetrodotoxin and pertussis toxin. Those that use these would be labs like our neuro-science labs. The intent of this bill is focused mainly on microbiological labs. How will you be contacting labs to alert them when this bill comes into effect that might have this in their possession to use for different purposes, but do not consider themselves part of the Public Health Agency of Canada or part of the national microbiology networks?
Dr. Tam: We have a communication strategy that would allow us to broadcast the bill upon Royal Assent in a very systematic and widespread way. We will use numerous networks, academic institutions and websites to promote it in numerous ways. We expect a lot of questions because there will be many situations where we may have to review them on a case-by-case basis.
Upon Royal Assent, people have to send us a name and contact information. That gives us a better idea where some of these other different circumstances might exist and we can address them appropriately.
We will be doing a major dissemination upon Royal Assent.
Senator Dyck: What about the suppliers where people get these items? Would they be part of your contact list?
Dr. Tam: Yes, people who export or transfer pathogens are included. For example, people who design proficiency testing panels to look at how well labs can identify viruses send these samples all over. They would get similar notices as well. Industry has already been contacted, but we will do further broadcasting.
Dr. Butler-Jones: There are also professional associations. We have a range of ways.
Senator Dyck: With regard to inspectors, you already mentioned that the Minister of Health will have an advisory committee. The bill sets up a process whereby that advisory committee will help the minister establish regulations for biological safety officers. Will the advisory committee also be involved in setting up regulations about qualifications and appointment of inspectors? Inspectors have broad powers and a critical role to play in the implementation of this bill.
Dr. Butler-Jones: The committee will be set up early on in the process once we have the act. The committee will be an ongoing process for reflection in addition to all the consultations. We have existing regulations around inspectors' qualifications, but for example, we will want to talk with provinces that already have a regulatory regime for laboratories. Could we piggyback with them rather than having two inspectors? They could have authority to do our aspect of the work as well as what they normally do. That will require a conversation with provinces, territories and others. It will also require looking at the required credentials, et cetera that would be necessary to address this.
Those are open questions. We are still interested in any advice and thoughts people have.
Senator Dyck: If I am correct, the bill says the minister would have to consult the advisory committee with respect to the biological safety officer, but I do not believe it says that with regard to the inspectors.
Dr. Butler-Jones: Our intent would be to do that.
Senator Dyck: It is the intention, but it is not within the bill itself.
Dr. Tam: That is not explicitly stated. The advisory committee is mentioned in two different clauses in dealing with risk groups in Schedules 1, 2, 3 and 4. The other mentions Schedule 5. That is more explicit.
We can take that into account in the development of programmatic aspects.
Senator Martin: I want to echo what Senator Segal said regarding how well our recent H1N1 outbreak was handled by the authorities and our minister. My question is in relation to that because it is something that dominated the news and preoccupied our attention and concerns. We have also learned from this recent experience.
How would this bill strengthen our ability to handle future outbreaks?
Dr. Butler-Jones: It will strengthen our response in a couple of areas. For example, the H2N2 pathogen was found in an individual. We traced it back and found it had been sent out as part of proficiency testing. In that case, it would make it easier to follow up because we know what labs have it; where it was sent; track it down; and have it destroyed.
I am not sure it would help with the current H1N1 virus. It is a novel virus. No one has it in a lab. It is not circulating. It is a new human virus. We are not sure where it arose, whether it is California, Mexico or Canada for that matter.
As Dr. Tam said, SARS was very different. SARS has a long incubation period. You had to be sick before you could transmit it. We are able to contain it through isolation and other means to stop it from spreading.
If H1N1 were like that or some other virus, once we were able to contain it, you can restrict who is using it if we know where the labs are. That is a big concern: If SARS is sitting in labs across the country that we do not know about, that is a potential risk for re-emergence. In that sense it is true.
Back to the 1970s case, people probably think the H1 came from a lab because it was sufficiently different from the 1950s virus and certainly from this one. Again, to know where that occurs is important so that it can either be limited or the problem identified so it does not happen again.
In Britain, regarding anthrax in cattle, that occurred around the lab that was using anthrax. It was only because you knew that or could figure it out. That knowledge may not have stopped it from happening but then you find out why it happened because you can go back and implement things in labs to improve that over time.
There are always surprises. One of the things about public health and progress in public health is that we prevent what we can. What you cannot prevent, you identify and learn from in order to potentially prevent it in the future.
Senator Martin: In terms of the international community, would you say this bill will strengthen our position or ability to track accurately and help in our international participation?
Dr. Butler-Jones: It certainly would help our responsibilities around the international health regulations, as Dr. Tam identified, with things like polio and being able to understand what we have and where we got it.
Senator Champagne: Thank you for your presentations. My question goes maybe a little bit beyond the scope of Bill C-11. I hear you say that you are worried about what is where — in which laboratories can this pathogen be found and so on.
Looking at the list of Risk Group 2, which is maybe somehow more benign than others, I found that there are some listed here which are really everyday occurrences and problems in some of our best hospitals. I am thinking for example of clostridium difficile, pseudomonas aeruginosa and staphylococcus aureus. Will we ever be able to stop the spreading of those bacteria in our own health system; in our own hospitals?
I do know what I am talking about. I got both neisseria meningits and staphylococcus aureus. I almost died but I am here and so happy to be.
I am wondering, when I see these bacteria on your Risk Group 2 list, I am wondering if Bill C-11 can stop someone from a lab from spreading those bacteria. Can you stop someone in a hospital from spreading it?
Dr. Butler-Jones: Thank you. That is a good question and I am glad you are here, too.
This legislation does not address issues of infection control in hospitals, which is part of what you are talking about. Another part of our work is working with provincial and territorial governments and others. We establish the guidelines around infection control et cetera. Clearly there are thousands of Canadians who die every year from infections they acquire in hospitals. That is a huge challenge.
Part of the advantage of the focus during the H1N1 about hand-washing and covering coughs is, hopefully, that hospital workers and others are also more conscious of the importance of hand-washing. I am the one — hopefully not me — but my colleagues and I are the ones who take influenza into nursing homes and spread it from person to person. It is not their family visiting; they go to visit one person. We go from patient to patient. In most jurisdictions, only half of us get a flu vaccine every year. We kill our patients because we did not get a flu vaccine. That is a huge issue. This legislation does not deal with that.
There is an exemption. It is not about laboratories that just do testing. It is really focused on those that retain, reproduce and do other things with these agents. It is also not about what is in the environment. Again, most of these bacteria are in the environment or in one of us. It is not about regulating, in some way, people who are infected or the environment in which you will find the bacteria. You find listeria in the environment all the time. We find anthrax in the environment and other things.
It really is about the laboratories that are handling these materials, not just for diagnostic purpose, but for research and other things.
Dr. Tam: I think you pointed out that someone who is taking a sample is not in the scope of this act. A laboratory technician taking a sample of a pathogen in blood must practice good infection control and practices which prevent themselves from acquiring the infection, which is not in the scope of this bill.
Even though a number of these bacteria are in the environment, in a lab it occurs in an unnatural environment where you are producing it in very high concentrations and growing specific organisms. That is very different from when it occurs in its natural state, even in a chicken or something. The lab technicians are handling it under very different circumstances.
I think that having good laboratory biosafety practices will prevent the laboratory technician from acquiring the pathogen, either on the hands or infecting themselves, and then spreading it. Certainly, the bill addresses potentially the safe practices of handling pathogens and not transferring them to outside the lab, which could be the community or an institution.
Senator Segal: There is a syndrome which breaks out in Ottawa from time to time called ETP — which is Excess Testosterone Psychosis. If, as a result, we find ourselves in an election and this bill is lost before it can be dealt, would you say there is a heightened risk with respect to pathogen management over the next six months until Parliament comes back?
Dr. Butler-Jones: It is an ongoing risk. We have already had that experience once. I do not know about your diagnose of the reason. This is the second time this has been forward. It was many years in the making in the first play to try to get it as right as possible. We will not be worse off but the longer we wait, the longer the risk remains.
The Chair: Let me close with a quick question. We talked about public safety, and appropriately so. There is also a question of patient safety.
You have talked about extreme cases where somebody leaves something in a fridge and it is dangerous. However, there is also a lot of everyday activity that goes on in laboratories with respect to diagnostic work with specimens from different patients for different reasons.
Will this be made more difficult for these people? When I say ``patient safety,'' if there is a delay because of new administrative procedures to follow and getting word back to the patient's physician with respect to a problem they may or may not have, that creates additional anxiety. Will it be an administrative difficulty for people in those day-to- day activities? Most of these pathogens would be in Risk Group 2, I would imagine.
Dr. Butler-Jones: This actually does not apply to that situation. That is diagnostics, as Dr. Tam was saying: Taking samples, blood samples, cultures for diagnostics, et cetera. However, the expectation would be — and it is not about this legislation — that every hospital lab in the country follows good basic biosafety for the protection of their workers and for the protection of others in the hospital.
As Senator Champagne was saying, hospitals are important places to be when you are sick but are full of nasty bugs. The more we can contain those, the better. This bill does not address those issues, however.
The Chair: Thank you to you Dr. Butler-Jones, and to your two associates for being with us.
In the next segment of the program we have Prof. Elaine Gibson, Associate Professor, Health Law Institute, Dalhousie University. Her areas of expertise include health law, privacy law and negligence. Professor Gibson participates in a number of research projects concerning the privacy and confidentiality of electronic health information focusing on the uses of information in the areas of health research and public health surveillance.
Elaine Gibson, Associate Professor, Health Law Institute, Dalhousie University: Thank you for inviting me. The first thing I want to say in response to what I have been hearing is that the Public Health Agency of Canada was quite responsive to many strong critiques they were hearing before the House of Commons Standing Committee on Health. However, they did not address all the concerns and there are serious concerns that remain out in the research community, and at the provincial government level. The concerns can be summarized as potential cumbersomeness, cost and criminalization.
I also believe the Privacy Commissioner of Canada has some concerns that linger, and if I have time I will get to those. I will start by addressing a couple of areas that tie in with my legal focus.
One is the extensive use of regulation as opposed to having the substance within the bill itself. The other is constitutionality, i.e. division of powers with the provinces, and the third, if I have time, is privacy and confidentiality.
As I said, there are a number of concerns. When these were raised, the answer to the research community and the provinces was, it is okay, we will go through full consultation as the regulations are being developed and we will be good, we will not put too many burdens on you. I think that this is problematic as a general approach for Parliament. I mean both for the House of Commons and for the Senate. It may be an exaggeration to say that it is a subversion of the supremacy of Parliament, but it wanders into that area when so much is left to regulation.
I have not heard strong justification as to why the consultation should not happen first and then a bill be brought forward in its fullness and that includes a great many of the details at least, and leaves certain administrative matters to regulation.
The core problem here is that it leaves decision-making to the ministerial level. This was a concern I raised before the House of Commons Standing Committee on Health. There was a partial response in a revision to the bill, and that is that it includes a reporting back to both houses of Parliament before regulations are approved. To my knowledge, the only time this was done before was with the assisted human reproduction act.
There are problems with this though. I do not think it answers everything. First, there are many fewer protections. The minister need not accept the recommendations of the standing committee when it raises concerns about what will be in the regulations. He or she just needs to take them into account, whatever that means. Also, the regulation can be altered after review and it need not go back before Parliament after alteration. Also, not all regulations need to follow this basic process.
Fundamentally though, the problem is that it is a work-around, to use a phrase from the technology community, an attempt to fix a problem with a band-aid solution. The problem, in my view, is that the bill is not complete.
Senator Eaton, in her introduction about the bill, said that this bill is the foundation and frame of the house and it has been presented that way, certainly. I just ask why do you not want the house to be built before you actually make the purchase? My basic suggestion is that too much is being left over to regulation, and the Senate and the other house will have arguably relinquished too much authority to the ministerial level, leaving it to the whims of a particular government.
Now, on the constitutional issue, does the power exist at the federal level to regulate in this area? The Public Health Agency of Canada indicated it is relying on the criminal law power and there is some strength in going in that direction. There is fairly wide room given by the Supreme Court of Canada to the use of criminal power in the area of public health, as has been mentioned, but there are problems with this approach. In a nutshell, the more regulatory a statute, the less likely it is to fall under the criminal law power. To the extent to which the guts of the bill are being left over to regulations, the more regulatory the act appears to be, as opposed to criminal.
It is important to distinguish between bio-terrorism and bio-safety. Substances potentially used for bio-terrorism — anthrax and smallpox, a short list — fall most likely into Risk Group 4, the highest risk, or schedule 5, prohibited. That is fine. If it is to prevent bio-terrorism, clearly it is criminal. However, once you are talking about bio-safety, it is a different matter. This is the prevention of unintentional exposure to pathogens and toxins, and their accidental release. This starts to look less like a criminal matter and more like a provincial responsibility, especially when talking about substances in Risk Group 2. For instance, E. coli, salmonella, others have been mentioned today, are substances that perhaps we can grow in our fridges or find in a pond.
This aspect of the legislation is primarily protecting the laboratory employees themselves against accidental exposure, and perhaps their families. This then falls much more closely to occupational health and safety, which is clearly provincial jurisdiction. Therefore my basic suggestion there is that Risk Group 2 be removed from the bill.
The requirement of reasonableness has been added to proposed section 38. It should also be added to proposed section 41(2), the powers of the inspector to seize materials, copy documents, et cetera. The inspector should be required to have a reasonable belief that these are necessary for the purposes of the investigation.
You heard from counsel earlier that these are ``read in'' by the Supreme Court of Canada. However, I do not understand why you would not actually include those in the legislation if that is the case so that every inspector on the ground actually knows that. They should have a reasonable suspicion that an offence has occurred.
Next there should be a general confidentiality clause, and a general requirement that the minimum amount of information necessary for the purpose be collected, used or disclosed. Finally, it should be in as de-identified a state as possible.
I urge the committee to invite the Privacy Commissioner to appear on these matters. Two letters from the Privacy Commissioner that were tabled to the House of Commons Standing Committee on Health. There are concerns about the previous handling, including there not having been a privacy impact assessment and that she was not invited to appear before the Standing Committee on Health.
I mention one more thing about privacy and confidentiality, and that is that the powers of disclosure by the minister in proposed section 39 are still too broad. You can see more comments on that by the Privacy Commissioner in her letter of March 11. Basically, as Senator Segal pointed out, all of the concerns about privacy and confidentiality potentially invoke the Charter of Rights and Freedoms section 8, the right against unreasonable search and seizure. Those are my opening comments.
The Chair: Let me ask first of all about this criminalization matter. I appreciate your comments. You said you are separating bioterrorism from bio-safety. I do not think we would have any problem with criminalization being part of the bioterrorism process, but certainly criminalization does not cover all of these concerns that can come about as a result of this piece of legislation.
What is an alternative? Perhaps you covered this to some degree, but what is the alternative in terms of penalties for wrongdoing that are short of criminalization?
Ms. Gibson: Four provinces have laboratory licensing acts: Quebec, Ontario, Manitoba and Saskatchewan. Primarily, the licensing of laboratories has been regulated at a provincial level. There are aspects of this that are clearly federal, as we have said, and one of which is the use of smallpox. An absolute prohibition in the legislation is the use of smallpox by researchers or laboratories.
It is a good question because certainly it is important, I think, that the Public Health Agency of Canada have this information. It is certainly open to voluntary sharing for those provinces that have a regime that covers it. We already have covered off the importation and exportation of these pathogens by the federal government.
One alternative that I mentioned, but I will stress again, is the removal of Risk Group 2 pathogens and toxins. Those can be removed from the bill. When you are down to that level, it looks much more like a licensing regime, and when you are at the more serious level, where there are aspects of bio-security, it can look much more like criminal jurisdiction.
The Chair: You used three words at the outset. Criminalization was one, and you also used cumbersomeness, and cost I thought was the other one. Could you amplify on those terms?
Ms. Gibson: When you set up a system of licensing and inspection, then the labs themselves of course will be subject to that; and the cumbersomeness is a concern I have had expressed to me by at least one provincial health authority. If labs are trying to function and are subject to inspection and perhaps onerous — we do not know yet — requirements of licensing and security clearances, they may be impaired in the work that they do.
Could I mention one more concern about that, by the way? If you look at the testimony of some of the witnesses before the House of Commons Standing Committee on Health, at least one said that when the U.S. brought in somewhat similar regulations, that many of the labs stopped their research work because they found it too cumbersome. This, I propose to you, is counterproductive because we want the research on these pathogens and toxins to proceed.
Senator Eaton: Thank you, Professor Gibson. May I make a few points? I have read the bill, have been briefed on it and have a very different interpretation of it. I will start by some of the things you were saying about provincial regulation, how there should not be regulations and it should be in the act itself.
I think the idea of having a stage two, where things like inspection and licensing would all be by regulation, was because the provinces have safety and labour guidelines in place. They are different; there is a sensitivity that each province has different concerns, so I think the consultation and regulation was so they could adopt and make a level playing field, hear the provinces out and adopt the best practices of each.
In terms of your concerns of inspectors, I think Senator Dyck made a very good point today. That could be further looked at.
With respect to the privacy issues, you have to allow Revenue Canada to knock on your door and go through your cupboards. We are trying to protect the safety of Canadians, and I think any lab that has bio-safety guidelines in place for their lab workers would not mind an inspector coming through saying, ``Are you sure you are cleaning these cupboards? How are you disposing?'' I do not see that as onerous, especially when it affects Canadians' health safety.
The criminal aspects of the act, I understood when I was briefed, were there as a last resort. If there was a risk to a lab — Dalhousie University, McGill University, University of Toronto — and something happened by accident and the inspector comes through, you will get a letter. If it happens again, you get another letter. It is just when a criminal act is carried out, and when there is proven intent, that you have something to fall back on.
One of your other words was ``cost.'' Dr. Tam spoke about it taking five years to bring many of these regulations into place. So the cost can be borne over several years and started early on. Most of our big university labs, as I am sure you are well aware, follow bio-safety standards; they have for years. This will not be a big deal for most of them.
What worries Health Canada and the minister is that we do not know about so many labs; we do not know what they have, and it would be nice to know that.
I am sorry, but it is cumbersome to buy a house these days; it is cumbersome to park your car. If you are using tuberculosis or anthrax or some of the pathogens and toxins listed in Risk Group 2, there should be some bio-safety guidelines in place. Yes, they are not as easily spread, the contagion is not as great as in Risk Group 4 or 3, but someone can still become very sick, and I do not think labs using Risk Group 2 should just be let off the hook. I am sorry; I do not agree with you.
Ms. Gibson: I did not expect everyone to agree.
Even the U.S., which has brought in somewhat similar legislation, does not go down to the Risk Group 2. Despite all the flurry of activity we have seen in the U.S. post-9/11, even they do not go to regulating the types of pathogens that we see within Risk Group 2, or at least many of them.
As to the concerns about cost, et cetera, I am expressing to you what I am hearing from the researchers and from the provinces. I am not a core researcher working with these pathogens. I am passing on what they are saying, and I expect you will hear more about that next week when you meet with them.
Senator Dyck: I will ask you the same question I asked our previous witnesses with regard to the inspectors. The current bill states that the Minister of Health must consult an advisory committee with regard to the qualifications and the appointments of biological safety officers, but it makes no reference to the minister having to consult this group with regard to the inspectors. The inspector role seems to be important because it is the inspectors who will actually go out and check out what is happening in thousands of laboratories across the country.
Ms. Gibson: Your question goes to the point that I was first making about leaving so much to regulation. We do not know what will happen in terms of training, et cetera, of inspectors.
I understand that that advisory committee was a change from the previous bill. Their role is to be consulted on the levels of risk and the lists of what fits within each of the categories, from Risk Group 2 up to Risk Group 4 and Schedule 5. I do not believe there is a provision for them to serve another role at the moment.
Senator Dyck: Do you think they should be involved in setting up the system for biological safety officers and inspectors?
Ms. Gibson: I believe the advisory committee was added to the bill in order to address concerns that the present lists may be unwise or have certain aspects that should be altered. That is the small role that has been envisaged, in my understanding, for the advisory committee at the moment. If you think that it should be a seriously enhanced role, then that would be an interesting avenue.
Senator Dyck: I am asking you if that should be the role.
Ms. Gibson: If the Public Health Agency of Canada were sitting in this seat now, I think their answer would be, ``We will be doing that through extensive consultations with the communities.'' They would say, ``We do not think we need an advisory committee to do that.''
I am urging you to insist that this bill include all of those provisions as appropriate and that it not be left over to regulation.
Senator Segal: Thank you very much for your presentation. I would be interested, because you have taken a view across the health sector on some of these legal questions, in your assessment of best practices elsewhere. We have seen this previously and it has nothing to do with the party in power: Bureaucrats are faced with a problem, and hard- working, honest bureaucrats have to come up with a solution. How do you make the world safer? The bureaucrats could recommend consultation on a public registry or contract compliance for all those labs that get research dollars from the federal Crown. There are a million instruments available, but the one that is, in a sense, the least cumbersome for them and any federal government is to create a criminal violation in an act which says, ``If you do things, you are susceptible to certain penalties.''
I worry that that has happened in the past. If you look at Bill C-6, which is coming through the pipe with so-called hazardous products, you will see a similar construct to what is in this bill. I am concerned about what I would call boutique criminalization. When my party was in opposition, we used to attack the government of the day for excess taxation in provincial economic activity. Then when the provinces had no capacity to advance their cause, the federal government of the day would announce boutique federal programs to solve the problem in a way that was politically attractive. We used to say it would be better leave the jurisdiction where it exists and give the provinces the financial capacity to do their constitutional work. Labs and those safety issues are clearly within the purview of what many provinces and ministers of health of provinces would say is their existing constitutional jurisdiction.
You have made some specific recommendations for how this bill could be strengthened. My question is, is there another approach that might be more effective rather than criminalization of these sorts of activities?
Ms. Gibson: That is an excellent question. I would have to think for a few minutes about it, but I will start talking regardless. Four provinces already have legislation in this area, and how laboratories function and whether they get inspected and how they handle these materials appears very obviously to be primarily a provincial matter. Aside, that is, from importation and export, which is already covered off federally. The most amenable approach may be to have provincial legislation that reflects the primary jurisdiction, with agreements for the sharing of the information with the Public Health Agency of Canada, as is being worked on in other areas to do with personal health information.
The Chair: The Assisted Human Reproduction Act was passed here, and Quebec challenged it in the courts. It is still in the court system. It is going up to the Supreme Court of Canada, I believe. Is there any indication in your examination of this about how the provinces feel about this particular bill, or Quebec for that matter, which challenged the other one? How similar is the situation?
Ms. Gibson: Substantial portions of the Assisted Human Reproduction Act have been declared unconstitutional by the Quebec Court of Appeal. The case has now been heard by the Supreme Court of Canada, I believe in late April, but we do not have a judgment yet. The Court of Appeal said these provisions attempting to criminalize aspects of assisted human reproduction are primarily a colourable attempt to regulate the area. Again, we do not have the judgment of the Supreme Court of Canada yet, so we do not know what they will say to this, but it is certainly a cautionary note about whether this is constitutional or not.
When you set up a scheme that is primarily saying, ``You all need to get licences, and if you do not and you conduct these activities, then it will be criminal,'' which is primarily what is being done in here, as well as a couple of other things, that is very similar to what was happening in the Assisted Human Reproduction Act.
Also, I believe the scheme that is included in here for reporting back when a regulation is to be passed was taken from the Assisted Human Reproduction Act. That did the same sort of end run around whether these matters should come before a committee by kind of pasting it on instead of having the substance of the act address the issues.
In the five years since the act has been passed, only one regulation has been passed. The act is already up for review on the basis of a five-year review and the regulations still are not there.
The Chair: We would be happy to take any further thoughts to Senator Segal's question at a later point in writing.
Senator Keon: Your last statement focuses on the point I wanted to raise. You basically said let us get the regulations done and put some of them into the act before it is passed.
Paradoxically, the bureaucrats are saying it will take us five years to write these regulations, but they will probably come back to both houses of Parliament as we go along. Is it worth delaying this legislation for five years in your opinion?
Ms. Gibson: That is an interesting question. I would have to reflect on what I heard them say the legislation will do in the meantime. I think it will do some very basic functions. I do not know that we have had an issue in Canada that would be addressed by having those basic functions. For the major functioning of the statute, the delay will happen either way regardless.
There are two ways that it could be approached. The preferable way, and the way that legislation should be made, is to have adequate consultation and draft the act to include appropriate provisions. That is not happened yet in this case. Full consultation is being deferred. One way to proceed is to not pass the legislation, have the full review and then bring in legislation. I would not object to that approach. I think that that actually would be the superior approach.
Stepping down from that somewhat, would be to remove risk group 2. That would help with the constitutionality of the legislation. It would also help with some of the major concerns of the research community. That is to say, researchers are saying, we deal with this kind of stuff all the time and we deal with it fine, thank you very much. It will cripple our ability to conduct research by including these risk group 2 pathogens.
Senator Dyck: With regard to delaying the legislation, my impression was that it was important to have the bill in effect so that we could know all the places that have human pathogens and toxics. We are told there may be as many as 3,000 or 4,000 places currently that have these agents and without our knowing where they are. We do not know what they have or where they are located. It would seem to be important to know where they are so we can have a national database of where these agents are located.
Ms. Gibson: This is outside of my area of expertise. It is an appropriate question, but not one I am in a position to answer, unfortunately.
Senator Eaton: I would support what Senator Dyck was saying. On Royal Assent the bill will provide the who, what and where. They believe there are many labs that have never imported or transported and are able to operate with pathogens and toxins without anyone knowing who or where they are and what they have.
Senator Segal: In terms of the relationship between regulation and legislation, there would be nothing that would prevent the Crown at the Privy Council level from enacting a regulation to the Public Health Agency of Canada Act to require all labs to register these specific pathogens. They would not be in violation of the existing act to do so. That raises the question about why they might have felt criminalization was a better instrument than doing something as simple and direct as that.
It is a legitimate aspiration for Dr. Butler-Jones to have the right to know where these pathogens are. He could request the Crown prepare a regulation to his act to give him more authority.
Ms. Gibson: They might not have the right to know from a legal perspective. That is why I am raising the constitutional issue.
The federal government is in a bit of a bind in having obligations under international health regulations to report, but not necessarily being entitled to that information from the provinces. It is not obvious. You would have to look specifically to the regulation-making power under the act that creates the Public Health Agency of Canada. If it was not criminal, then it may not be within federal jurisdiction. That is why the criminal route is being taken here.
The Chair: We have come to the end of the meeting. Thank you, Professor Gibson for giving us your thoughts and answering our questions. We would appreciate anything further you have on this in writing. If you can do a summary of what you have told us today, it would helpful at our next meeting when questioning other people who will appear and for exploring further the areas that you have raised.
Honourable senators, I want to give you an idea of the next meeting and get any feedback you may have on anyone else you think we should invite. I have tried to come up with a mix of people who support or oppose the legislation. It is people asking for modification in most cases. I do not know if anyone opposes it outright. They are largely asking for amendments.
We have confirmed: Marc Ouellette from Laval University; the Ontario Association of Medical Laboratories; the Association of Faculties of Medicine of Canada; and a professor from the University of Toronto. We are waiting responses from someone from the McLaughlin-Rotman Centre for Global Health, someone from the Association of Medical Microbiology and Infectious Diseases Canada and Dr. Don Low — known to many people in this area — the Medical Director of Public Health Laboratories in Ontario.
The Privacy Commissioner was mentioned; we should include her. Is there anyone else?
Senator Dyck: Could we have someone totally new that has not appeared before?
The Chair: Some of these people are new. It is not all a repeat. A couple of them appeared before the House of Commons and a couple did not. Others said their concerns have not been considered. Some want to speak to the amended bill because when they appeared before the House of Commons committee on Health, they were speaking to the bill prior to amendment.
Senator Dyck: Coming from Saskatchewan, I like to put in Saskatchewan people. If there is a vacancy, you could get someone from the Vaccine and Infectious Disease Organization that is almost as significant as the National Microbiology Laboratory in Winnipeg. It is a major research organization dedicated to vaccines.
The Chair: Is this the same as the Association of Medical Microbiology and Infectious Disease Canada?
Senator Dyck: No, VIDO is the acronym. They are internationally known.
The Chair: We have the invitations out for these people, which is more than enough to fill our agenda, particularly when you add the Privacy Commissioner. However, they have not all responded.
Senator Segal: Further to our last witness's testimony, could we get a summary of the regulatory powers under the Public Health Act that govern Dr. Butler-Jones's activities, so we can compare it with what has been presented to us in this legislation?
The Chair: Yes, that is reasonable. Is there anything else? Thank you very much.
(The committee adjourned.)