Evidence of meeting #12 for Health in the 40th Parliament, 2nd Session. (The original version is on Parliament’s site, as are the minutes.) The winning word was regulations.
A recording is available from Parliament.
Conservative
The Chair Conservative Joy Smith
Good afternoon, ladies and gentlemen. Welcome again to committee.
You will notice that there are two motions being handed out. We will go very quickly to Dr. Duncan's notice of motion. It will take just a couple of minutes.
First of all, Dr. Duncan, you will have to have the permission of the committee to change your motion. Then we will do a yes or no on it. You have the floor.
Liberal
Kirsty Duncan Liberal Etobicoke North, ON
Thank you.
Good afternoon, everyone.
We had previously discussed neurological disorders. My initial motion in that regard was very ambitious as drafted. I've decided to reduce it a bit. I would begin by asking your permission to change that motion.
Liberal
Kirsty Duncan Liberal Etobicoke North, ON
Thank you.
At the dinner with the minister, we had a long discussion about neurological disorders and the lack of attention and money they receive here in Canada. I am hoping that we could strike a subcommittee to look at neurological disease in Canada, particularly autism, MS, ALS, Parkinson's disease, and Alzheimer's; to look at new technologies, which are yielding positive results in other parts of the world; and to investigate the possibility of bringing successful therapies here.
Conservative
The Chair Conservative Joy Smith
What we're going to do very quickly is look over the motion. I'll just read it out, as follows:
That the Health Committee should strike a sub-committee or have a conference to examine the burden of neurological disease in Canada; explore results of clinical trials and experimental technologies, which are yielding positive results here in Canada and internationally; and investigate the possibility of bringing successful therapies to Canada.
We can discuss this at a further point. Are we in agreement--by a show of hands--that we should either have a subcommittee or a conference at some point in time to take a look at this particular condition?
Conservative
The Chair Conservative Joy Smith
That's passed.
With your permission, Dr. Duncan--I know you have to get to the House to speak--what we'll do is discuss this at one of the subsequent meetings as to whether or not it should be a conference or a subcommittee.
Liberal
Conservative
The Chair Conservative Joy Smith
You're so welcome.
Welcome to our witnesses. Once again we are having testimony in terms of Bill C-11. We have the Public Health Agency of Canada, the Institut national de la recherche scientifique, Laval University, McGill University, and the McLaughlin-Rotman Centre for Global Health.
Without further ado, we will ask one person from each organization to give a 10-minute presentation, if they so choose. We will start with the Public Health Agency of Canada.
Who would like to make this presentation?
Dr. David Butler-Jones.
Dr. David Butler-Jones Chief Public Health Officer, Public Health Agency of Canada
Thank you once again for the opportunity to further discuss this critical piece of legislation with the committee and witnesses.
Obviously l've listened with interest to the comments presented at standing committee over the last few weeks and understand the importance and the relevance of the views that stakeholders have brought forward. It's in everybody's interest to have the best legislation possible. I have indicated that I am open to discussions on how the bill could be strengthened.
The perspectives that have been presented by a variety of witnesses show the value of what we are trying to achieve and the importance people place on getting it right. Human pathogens are dangerous, as they are capable of causing disease and death. For that reason, we have to be diligent in creating a legislative base that balances biosafety with not restricting scientific advancement--providing assurances, at the same time, to the Canadian public and our international partners that Canada takes the biosecurity imperative seriously.
In order to achieve that much needed balance, I want to reinforce that we are committed to continuing this dialogue and to working closely with our partners and stakeholders. We will develop a program and regulatory framework that responds to the needs and the interest of the scientific community while improving biosecurity and biosafety.
In terms of this discussion, there are some questions that have been raised that I want to address directly.
First, why do we need this legislation now? Why not take more time to consult on the legislation before the in-depth consultations on the program and regulations?
As Chief Public Health Officer, I have recommended that we develop legislation that establishes a safety and security regime for all laboratories to protect the health and safety of the public.
Going forward, consultations will help determine what this regime will look like. We are committed to framing these consultations in a way that will best suit the needs of provinces and territories and our stakeholders and partners in the academic and hospital communities.
All of our international counterparts have had similar legislation in place for years. Although Canada has not experienced a large intentional or unintentional release of a dangerous agent, this is not a reason for complacency. We have had some close calls in this country.
We have had some close calls in this country.
As an example, in April of 2005, a facility in Canada imported a live virus sample under a risk group 2 permit. Upon laboratory analysis, it was realized that the material was contaminated with a risk group 3 human pathogen, an influenza H2N2 strain.
Once the contamination was confirmed, the Public Health Agency of Canada's importation office, the Office of Laboratory Security, in consultation with the WHO, the U.S. Centers for Disease Control, and the provincial health ministries contacted the supplier of the material and all facilities in Canada that had been issued a permit for the same panel and advised them of corrective action.
It was only because the material was imported that the federal government was able to track who had the affected materials.
Should this situation happen today in Canada with a domestically produced product, there would be no authority or ability to track materials and advise affected parties of corrective action. This could result in a biosafety and biosecurity risk. Canadians would have had no immunity to this virus, possibly creating the conditions for the next influenza pandemic.
If something like this were to happen, Canadians would demand and have a right to an explanation for why we did not and could not protect them. There is an opportunity, through this bill, to make Canada safer.
The second important question that has been raised has focused on speculation around the potential cost of the program and the regulatory framework and the perception that these costs will be onerous. We have anticipated and listened to the concerns about cost. This issue is front and centre for us in terms of the development of the associated program and the regulatory framework, and we'll continue to work towards achieving that goal to develop a cost-efficient and effective program.
As witnesses such as Mr. Leitner, who have implemented or are implementing biosafety and other regulatory activities, have indicated, neither the impact nor the cost of these activities has been onerous. However, the cost of inaction in terms of dollars, our credibility, and human life is potentially far greater.
As the committee is aware, other concerns are identified and addressed in the draft regulatory framework and through our commitments on the process of consultation.
Finally, I want to address the question of our willingness and commitment to listening to our partners and working together.
We have taken and continue to take action to address concerns that our partners have raised. These have been excellent, productive discussions. Our partners have told us that they are comfortable with the actions we are taking, and I am optimistic that we are going to move forward together.
Specifically, I have been in direct contact with the Province of British Columbia, including Mr. Gordon Macatee, deputy minister for the B.C. Ministry of Health Services, Grant Main, deputy minister, and Andrew Hazlewood, assistant deputy minister, as well as Dr. Perry Kendall, B.C. Provincial Health Officer, and others.
I've spoken with Ms. Arlene Wilgosh, deputy minister in Manitoba and provincial-territorial co-chair of the conference of FPT deputy ministers.
Further, I've spoken with Dr. Vivek Goel, president and chief executive officer of the Ontario Agency for Health Protection and Promotion, Mr. Ron Sapsford, deputy minister of the Ontario Ministry of Health and Long-Term Care, and Dr. David Williams, acting Chief Medical Officer of Health for Ontario.
We have had a follow-up conference call with the Council of Chief Medical Officers of Health and the Canadian Public Health Laboratory Network, and further discussion will continue over the coming weeks.
Finally, I've also spoken with the Privacy Commissioner, Ms. Jennifer Stoddart, and Dr. Lorne Babiuk, from the University of Alberta, on behalf of the group of university vice-presidents of research.
Beyond my personal interventions, there have also been a number of other discussions by officials with provincial, territorial, and academic partners, as well as with the Office of the Privacy Commissioner.
We continue to work very hard with these partners in order to ensure all relevant issues are addressed, and we are committed to them over the long term. I believe that as a result of these interventions there is broader understanding of what the government is trying to achieve through this bill. In addition, I have heard their messages regarding various ways to improve the overall intent of the bill and its future regulations--discussions that have been very fruitful and will continue to be as we go forward.
Ultimately, our partnerships are not only about the development of legislation or regulation, but about the fundamental collaboration and cooperation required to continue to protect the health and safety of Canadians in all respects.
Thank you.
Conservative
The Chair Conservative Joy Smith
Thank you very much, Dr. Butler-Jones.
We'd now like to go to Mr. Descoteaux.
Dr. Albert Descoteaux Professor, Institut Armand-Frappier, Institut national de la recherche scientifique
Thank you again for giving me the opportunity to express some fears or concerns about Bill C-11. I would like to take the opportunity to raise a matter that went unnoticed last time: bacterial toxins.
The CDC in the United States consider two or three toxins to be really dangerous. Most of the toxins on the list are very important research tools. We use them to study how cells work in cancer, in neurology and in immunology. Examples are the cholera toxin, the Clostridium botulinum toxin and the pertussis toxin. I am afraid that, if access to these toxins becomes too complicated, it could be very detrimental to research in cellular biology.
I also have some concerns about HIV. In the bill, HIV is classed at level 3. But it is a fact that several research groups and research networks in Canada have established sample banks, with samples taken from thousands of patients infected with HIV. These banks are invaluable for HIV research. One example is the Réseau SIDA et Maladies infectieuses, run by the Fonds de la recherche en santé du Québec. Members of that network have access to various banks of samples: from patients with primary infection, from slow progressors, and from patients infected with HIV and the hepatitis C virus.
Since HIV is now in containment group 3, I seriously wonder about the impact that Bill C-11 could have on the access to, and use of, these thousands of samples by qualified researchers. We can only imagine the bureaucracy and the permits needed for laboratories to exchange strains. And it is not just networks. Hundreds of professors and students need to handle and use these lines. We run the risk of setting up a huge logistical challenge, not to mention the impact on AIDS research.
I have to point out that these sample banks were established with grants from federal and provincial organizations. Bill C-11 would destroy all the financial commitments from government in the fight against AIDS. Paradoxically, that remains a federal government priority. I would really like that considered when you decide your position on Bill C-11.
There has also been talk of micro-organisms potentially being used for malicious purposes like bioterrorism. I have given Mr. Etoka a list from the Centers for Disease Control's website in Atlanta. The list is in English only and has not been circulated to everyone, but you can easily get it. It is a list of agents that can be used in bioterrorism.
The first thing we see is that the list of micro-organisms that are considered very dangerous is very short. There are six: anthrax, botulism, plague, smallpox, tularemia and the hemorrhagic fevers.
The second thing we notice is that these micro-organisms all belong to confinement groups 3 and 4, except smallpox, which is in group 5.
The third thing is this. In the list of micro-organisms that the CDC consider less dangerous because of their moderate morbidity and low mortality but that could still be potentially used for bioterrorism, some are in confinement group 2, like salmonella, some strains of E. coli, like 0157:H7, vibrio cholerae and cryptosporidium. In general, these are the micro-organisms most often responsible for food poisoning or contaminated water. Poisonings and contaminations of that kind are often due to poor hygiene practices or negligence on the part of the people in charge of water quality.
After I appeared here two weeks ago, I have had discussions with my colleagues and I have thought about the matter some more.
I would like to end with a recommendation. If the goal of lawmakers is to promote public health and safety in the area of micro-organisms and to protect Canadians from potential bioterrorist attacks, Bill C-11is not the solution. I feel that the bill could well create havoc by establishing a repressive system that lumps all micro-organisms together, whereas the vast majority of them pose no problem at all for people's health and safety. My recommendation is that lawmakers and the Public Health Agency of Canada concentrate on the few micro-organisms that potentially can be used maliciously and put in place appropriate measures for them.
Thank you for your attention. I will be pleased to answer your questions.
Conservative
Professor Marc Ouellette Professor, Laval University
I'll be very brief.
I am here mostly to answer questions. We have already given our presentations. I will just say that the four of us had only 24 hours' notice, and we are here.
because it's very important for us. This is the bottom line. It is very important. We hope this bill will be useful and acceptable to all. That's it.
Conservative
The Chair Conservative Joy Smith
Is that your presentation? It's wonderful. Do you have anything else to say?
Conservative
The Chair Conservative Joy Smith
Well, I think a lot of us are very anxious to ask some. Thank you.
We will now go to Mr. Matlashewski.
Professor Greg Matlashewski Department of Microbiology and Immunology, McGill University
I'll also be brief, because I know you've heard a lot of different discussions.
I read the comments that you heard recently from Elaine Gibson, and I would like to support them. The most important thing is to get this bill right so that everybody concurs that it's the right thing to do.
I think it's really important that the regulations be included within this bill, because otherwise the bill is an empty shell. You're having a law in which the regulations can come and go and change from one government to another government. The bill will mean very little without real regulations within it, as far as I'm concerned. I think there's a real danger in passing this bill without having the regulations, because I've seen some of the amendments, and these amendments have not changed the bill substantially. If these kinds of amendments are what is envisaged for the regulations, then I think there are going to be some real problems in the future.
I would like to slow everything down and go back and put the regulations into the bill. This way we'll have a bill that will serve Parliament better and serve Canadians better.
Conservative
Dr. Peter Singer Director and Professor of Medicine, University Health Network and University of Toronto, McLaughlin-Rotman Centre for Global Health
Thank you, and thanks for the invitation back. I'll also be brief, because I understand the primary purpose is to respond to questions.
The first point I'd like to make is that I very strongly support the need for legislation on this matter of pathogen security. I actually think there is some urgency to passing the right legislation. For example, a U.S. congressional committee late last year found that it was more likely than not that there would be a weapons of mass destruction attack somewhere in the world by 2013, and a biological one was more likely than a nuclear one. So we don't want to drag this out for months and months and months.
Secondly, having said that, I'd like to focus my remarks by really zeroing down on the question of the inclusion of level 2 pathogens in this bill. I would like to tentatively put forward a position or pose a question—maybe even do this in a type of question-and-answer format, since we have this great opportunity of being here with Dr. Butler-Jones and his colleagues, whom I have a great degree of esteem for—and maybe Dr. Butler-Jones and his colleagues would be able to respond.
Wouldn't this be a better bill if level 2 pathogens were just taken out of it? I want to advance four lines of argument around this supposition.
First, I didn't hear in any of the testimony real evidence and proof that the inclusion of level 2 pathogens makes us considerably safer. You'll remember that my testimony last time had to do with the point that pathogen security does not equal biosecurity, especially when you're talking about level 2 pathogens. I would just like to hear more of the case that the inclusion of level 2 pathogens is actually a very, very significant benefit.
My second line of argument is that if the criminal penalties were reduced for level 2 pathogens—and that would be an obvious move to make in amendments—you're still going to be left with criminal penalties. And that's a very, very significant thing for scientists. In a nutshell, you could get into a situation where sloppy record-keeping on the part of a scientist in a relatively low risk, level 2 lab, or by a student or faculty member—though the faculty member would probably be accountable in this case, or the university—could leave someone with a criminal conviction. Even if there were no fine or jail term, that person couldn't then travel to the United States. That's a very serious use of the criminal law in a relatively low-risk situation.
The third line of argument I would like to advance, just in this hypothetical case of it being a better law if you took level 2 pathogens out of it, is the comparison with the U.S. In the days since I heard from the clerk, I've been in touch with some biosecurity colleagues in the U.S. I asked them about regulation of level 2 pathogens in the U.S. It turns out that what's criminally and federally legislated in the U.S. is this U.S. list of select agents and toxins. If you read the stuff on the U.S. select agents list, it correlates mostly with what's in schedules 3, 4, and 5 in Bill C-11, I think, exclusively—but I haven't done this in detail. Maybe there's one that's in level 2. But to my knowledge—and I would be interested in the response from PHAC colleagues—I didn't find any level 2 pathogens from Bill C-11 on the U.S. select agents list. Everything else is regulated, but not federally and not criminally, in the United States. So I left this list wondering if a somewhat bioterrorism-obsessed country like the United States, which passed legislation in the wake of an actual attack, doesn't even regulate level 2 pathogens in a criminal and federal way, why would Canada do that?
Finally—and this is an issue of leaving the matter for regulation, and again focusing just on level 2 pathogens—imagine you're regulating level 2 labs across the country. Imagine the horrendous, but not impossible, scenario of there actually being an attack. What will the cabinet do to those regulations the day after the attack, when there's considerable pressure to change them? Do you really want a situation where the level 2 pathogens, which can be relatively low risk, are in a piece of legislation, with regulatory provisions for them, and cabinet can change those regulations in a climate of fear after an attack, and do so without going back to Parliament?
That's why it's the day-after-the-attack scenario that I want you to think through.
I'm perfectly comfortable if on the day after an attack--God forbid that it should occur--cabinet does something with level 3 or level 4 labs. Those have very serious pathogens. However, at U of T, for instance, there are somewhere between one and three level 3 labs; there are hundreds of level 2 labs. They are relatively low risk and much larger in number. Do you really want to be in that situation of a climate of fear in which something can happen?
In summary, the legislation could definitely be made better by amending it to change penalties, security clearances, etc., related to level 2 pathogens, but I'd love to hear a response to the idea that this would be a better bill if you excluded them totally. You could pass the bill very quickly by doing so, and I believe this is a good bill and should be passed very quickly. Again, are the benefits really so great for level 2? Criminal penalties are serious, and I'll mention again the U.S. comparison the day after the attack.
In closing, I'd like to say that we should not just leave consideration of level 2 pathogens and the security issues around level 2 pathogens. That's exactly the sort of question that could be referred, as I mentioned in my earlier remarks, to the Council of Canadian Academies, the Canadian Academy of Health Sciences, or the Canadian Academy of Engineering. I would love to see an assessment by the academies of the way of dealing with level 2 pathogens or labs that would make this country most secure. I can't guarantee they'd immediately get to the legislation that would answer that question. They might, and if they did in a year or two, this legislation could be amended, but there are so many other things that could be done, including dealing with issues around next-generation threats and the web of protection I mentioned last time.
I feel that would be a better way to deal with level 2 pathogens, and then the government would be acting extremely responsibly. It would have closed this hole on regulation of level 3 and level 4, which is desperately needed--and I agree with this bill and the urgency for it--and it would not have left level 2 pathogens alone. It would actually be acting in a very responsible way in sorting out the best way to regulate them, and it would give the best advice to government, which is the role of the Council of Canadian Academies, on how to make this country more secure with respect to level 2 pathogens.
Thank you very much. I just put some probes there for my friend and colleague David Butler-Jones, and I very much look forward to the give and take that this panel allows.
Conservative
The Chair Conservative Joy Smith
Thank you, Dr. Singer.
We'll now go into the first round, a seven-minute round. We have seven minutes for the questions and answers. We'll start with Dr. Bennett.
Liberal
Carolyn Bennett Liberal St. Paul's, ON
Thank you very much.
I think we do want to see a to-and-fro in terms of the improvements that have been suggested by the government amendments, but also in terms of the lingering concerns, particularly those related to regulations.
I noticed that in his letter, Dr. Goel says that as much as he welcomes the amendments, any further means of ensuring transparency on the process around the development and approval of these regulations would be helpful. I would like to know from the Public Health Agency of Canada whether there's a way that process could be committed to within the bill. Then I would also like them to speak to the NDP amendment around bringing the regulations back to committee.
I wasn't sure whether the officials had seen the comments in response to the amendments by Elaine Gibson, because you wouldn't have seen her original testimony when the amendments were drafted. I will read it in to the record:
The Bill is improved in that the amendments clarify that there are different standards for Risk Group 2 in terms of security screening, regulations, and penalties. However, licenses will still be required for those using Risk Group 2 pathogens/toxins, it appears.
It addresses only minimally my concern that so much of the workings of this Act are being left over to be included in regulations as opposed to in the legislation itself. This is significant and ties in to concerns of the scientific community.
It doesn't address my concern regarding the constitutionality of including Risk Group 2 in that this appears more regulatory than criminal, and if so it may fall under provincial property and civil rights powers and not federal power over criminal law.
A number of concerns regarding privacy voiced [by] both the federal Privacy Commissioner and me have not been addressed--need for information to be in as de-identified a form as required for the purpose; need for adding the standard of 'reasonably required' in many of the more intrusive search and seizure powers. Also the Privacy Commissioner argued that a Privacy Impact Assessment needs to be conducted.
Could you respond to not only what the witnesses have said, but also to these concerns from two of the previous detractors?
Conservative
Chief Public Health Officer, Public Health Agency of Canada
Sure. Hopefully I'll capture it all. I'll turn to Theresa.
Perhaps I'll start with the last first. As I said, I've spoken to the Privacy Commissioner. Theresa met with her office yesterday. It's not about personally identified information; it is about the regulation of the materials. They're looking forward to it, and it is appropriate for the privacy assessment to take place when we're forming the program architecture for that, and their office is quite comfortable with that. So I think we've addressed their concerns as they are.
In terms of whether there should be an amendment come forward that brings it back to committee, for example, as an agency we have no problem with that. I've already committed, with or without it being in the legislation, that we are quite comfortable coming back to committee if it's the wish of the committee. As I said before, that's a legislative option.
In terms of the part I think you may have been alluding, regarding Peter's question about why it's level 2, I guess there are a number of reasons we include it. We already regulate level 2 now. It's in the regulations for import and export, and it's in the regulations for transport. Half the labs in the country are already under this regime.
I made reference to H2N2. The agency recognized it and was able to track it down because of the regulatory regime about import and export. If it were domestic, we would not have been able to do that. It came from the States. It was sent around the world as a sort of test kit, and H2N2 was put in there by mistake. Could you imagine the implications of the Americans having started the next pandemic unintentionally but intentionally in the sense of having distributed material?
We've also had instances now of abandoned laboratories and fridges full of materials, and the province not being in a position to actually compel information as to what's in there and who it's been sent to. So we need a minimal regulatory regime for level 2 to ensure that we have the ability to find out what's there and what's been sent where. I'm concerned about it from a public health standpoint as well as for consistency with the import and export. For most labs it should not mean much, if any, additional work.
Certainly with the concerns that were raised around HIV, etc.... Currently transport of level 2 pathogens requires forms to be filled out. The actual regime, if you look at the regulatory framework, is meant to minimize any efforts. It's really more focused on that if there's a problem, we will have the power or authority to actually address these issues.
Madame, was there another question that I've missed? I'm sorry.