Proceedings of the Standing Senate Committee on
Social Affairs, Science and Technology
Issue 5 - Evidence - June 17, 2009
OTTAWA, Wednesday, June 17, 2009
The Standing Senate Committee on Social Affairs, Science and Technology, to which was referred Bill C-11, An Act to promote safety and security with respect to human pathogens and toxins, met this day at 4:04 p.m. to give consideration to the bill.
Senator Art Eggleton (Chair) in the chair.
[English]
The Chair: I call this meeting to order.
Welcome to the Standing Senate Committee on Social Affairs, Science and Technology.
Our topic today for the third meeting is on Bill C-11, An Act to promote safety and security with respect to human pathogens and toxins. Today, we have the Assistant Privacy Commissioner and then we will have the Minister of Health and the Chief Public Health Officer appearing at 5:00.
Following that presentation and the question-and-answer period at 6:00, I would propose that we stay for up to half an hour beyond that, which would take us to 6:30, to discuss the further processing of Bill C-11. We can discuss at that point in time whether we want to consider amendments to the bill and whether we want to consider an observations report with or without recommendations back to the government.
We can go through that at that time, and we can ask our researchers to prepare what we want in the way of a report. Should we go that route, I would propose a fourth and final meeting, subject to your concurrence, on this coming Monday, June 22, at 2 p.m. The Senate is scheduled to go into session that day at 4 p.m., and the thought is that if we have completed the processing of this bill, we would then present it to the Senate later that day with our report.
What I need at this point in time is just your concurrence to go from 6:00 to roughly 6:30 on discussion on further processing. Is that agreed?
Senator Dyck: Mr. Chair, I just found out that the Standing Senate Committee on Aboriginal Peoples has the Minister of Indian Affairs appearing at 6:30, so if we could make it at 6:20 at the latest, I will have time to go over there.
The Chair: I am in your hands. It depends on what kind of discussion and how long the discussion takes with the members of the committee, but we will bear that in mind. Thank you.
Is that agreed?
Hon. Senators: Agreed.
The Chair: That is carried.
Let us now proceed with our first panel for this afternoon. We have Chantal Bernier, the Assistant Privacy Commissioner here on behalf of the Office of the Privacy Commissioner of Canada. She is here with Melanie Millar- Chapman, Senior Policy and Research Analyst.
We are ready for your opening remarks and will then get into some questions and answers.
[Translation]
Chantal Bernier, Assistant Privacy Commissioner, Office of the Privacy Commissioner of Canada: Thank you, Mr. Chair. I am Assistant Privacy Commissioner of Canada responsible for the Privacy Act, that is the act which applies to the public sector.
With me, as you said, is Melanie Millar-Chapman, a Senior Policy and Research Policy Analyst with our Office, who has done much of the background work on this file for our Office. Thank you for seeking our Office's comments on Bill C-11.
Today, I would like to describe our approach to Bill C-11 and state our position on the amendments that have been made since its introduction. I would like to clarify our position on the issues on which we have received explanation from the Public Health Agency of Canada and, finally, comment on the outstanding issue for the Committee's consideration.
So first, our approach to Bill C-11.
[English]
I must state at the outset that we accept and welcome the purpose of Bill C-11 in addressing a regulatory gap. We understand that several thousand laboratories in Canada which use domestically acquired human pathogens and toxins are governed only by a voluntary biosafety regime.
We determined from our discussions with officials from the Public Health Agency of Canada that Bill C-11 will cover laboratories in both private and public sectors, so there will likely be oversight from our office under the Privacy Act and under the Personal Information Protection and Electronic Documents Act, PIPEDA, which governs the private sector.
As you know, we were consulted by the House of Commons Standing Committee on Health, and we provided two letters in March 2009, both of which have been posted on our website.
Since the introduction of this bill, we have had detailed briefings from public health agency officials. We have also been pleased to receive some helpful correspondence from Dr. Butler-Jones to address the concerns we raised.
Dr. Butler-Jones has recently written to us to indicate that his staff would like to discuss the development of a privacy impact assessment. He has also invited us to take part in the consultation on the regulatory framework. Overall, we feel there have either been amendments to the bill to address our concerns or that we have benefited from a constructive dialogue with the public health agency officials that has helped us to understand better the proposed rules.
I would like to turn to the amendments to the bill. I want to begin by acknowledging that we are pleased that two of the amendments to Bill C-11 address concerns we had identified in our March 11 letter. Specifically, we were pleased that a reasonable grounds test was included in subclause 38(1) and that subclause 39(2) has been amended to restrict further disclosure of personal information unless the disclosure is required by law.
The other amendment we believe may improve the privacy protections in this bill is the new requirement that the regulations will be subject to parliamentary scrutiny. Clause 66.1, and the fact that Dr. Butler-Jones invited our office on May 29 to participate in consultations on the regulatory framework, leaves us optimistic about the regulation- making process under this proposed legislation.
I want to turn to the issues where we have received explanations from public health agency officials that provide us some comfort about the contemplated regime. First is the issue of ancillary personal information, such as patient information or information about a laboratory worker's family members. We had mentioned this in our earlier letter to the House of Commons Standing Committee on Health.
Dr. Butler-Jones has provided additional information to the point that our concerns around ancillary personal information can be addressed in the privacy risk assessment and discussions to come around regulations. We had always understood the value of the security clearance process for these facilities. However, we had been concerned that there was still nothing in the bill to restrict the collection of ancillary personal information.
For example, in our March 30 letter, we had raised concerns about possible collection of personal information about a laboratory worker's family members, should they come into contact with a regulated pathogen or toxin. We said we were mindful of the potential for function creep and would therefore prefer to limit the collection of personal information.
Dr. Butler-Jones responded to that concern. In his letter of May 29, he states that:
We believe that personal patient information would not usually be relevant to the administration of this Act or its regulations. In fact, in the fifteen (15) year history of the Human Pathogens Importation Regulations, on which much of the program under Bill C-11 will be based, we have not accessed personal patient information relating to a medical patient or the family member of a laboratory worker.
He goes on to say:
While we may want to know how someone became ill if the circumstances related to biosafety in a laboratory, we do not need to know who that person may be for the purposes of the administration of a human pathogens and toxins program. Information about how the person became ill could help us to adjust the Laboratory Biosafety Guidelines so that similar incidents do not happen in other laboratory settings, but, once again, the identity of the individual who became ill is not necessary in that respect.
Though it does not improve the language of the bill, I must say this clarification gives us some helpful perspective on current practices. We look forward to having an opportunity to discuss the safeguards that should be in place when we provide comments to our colleagues from the public health agency regarding the regulations concerning the collection, use and disclosure.
I now move to the second issue on which we have received satisfactory explanations from the public health agency to the point that our concerns are satisfied. We had earlier raised concerns about clause 41 being short on details about the inspector's powers to collect documents, materials, and information. We had questioned whether it might extend to the examination and collection of personal information and personal health information of individuals and patients.
Again, in his correspondence, Dr. Butler-Jones provided us with context for clause 41 and we note that subclause 41(1), which discusses the entry by inspectors, includes the requirement for reasonableness.
We noted Professor Elaine Gibson's remarks before the committee that the requirement of reasonableness that was added to clause 38 should also be added concerning inspectors' powers under subclause 41(2), so that inspectors on the ground might be clearer about their obligations. While we agree that this addition would further clarify the provision, we are satisfied with the fact that subclause 41(1) contains a reasonable grounds test applicable to subclause 41(2).
I now move to clause 67, interim orders. We had also expressed concerns about this issue. We stated that we believed that the use of an interim order to alter the regulations in an emergency situation might diminish controls over personal information. We had suggested that a reasonable grounds test would be beneficial in this provision.
Dr. Butler-Jones and his officials have made clear to us the exigent circumstances that would require the minister's ability to take prompt action on a temporary, exceptional basis. With this additional information on the context, we think that the approach set out in the bill is a reasonable one.
I would now like to put to you the outstanding issue I had mentioned at the beginning. We would draw your attention to subclause 39(2) which relieves the minister of the obligation to have a confidentiality agreement in place before disclosure of personal information, where, as described in paragraph 39(1)(b): "the Minister has reasonable grounds to believe that the disclosure is necessary to address a serious and imminent danger to the health or safety of the public.''
While we understand the reason to allow the minister to act quickly in situations of serious and imminent danger, we believe that it would be beneficial to ensure a written confidentiality agreement be put in place shortly after the disclosure under parapgraph 39(1)(b) has occurred. That is really the only change we are putting forward for your consideration today.
[Translation]
In closing, we look forward to continuing our collaboration with the Public Health Agency of Canada and there a few items we intend to raise when we are consulted on the regulations. For example, we had earlier recommended that, on the matter of retention of personal information, that retention periods be defined or subject to clear criteria. We had also suggested that officials maintain a clear account of all disclosures and know the rationales for them.
We are pleased with the changes that have been made to Bill C-11 so far. I would be happy to take your questions.
[English]
The Chair: Thank you. I will start off with a couple of questions and then turn it over to my colleagues.
You have said that this comes down to subclause 39(2) at this point. You feel the need for the minister to have a confidentiality agreement in place before disclosure of personal information.
Can you describe what kind of dangers you see in that? What could happen if that is not amended or not enacted in the way you suggest?
Ms. Bernier: The exception provided by subclause 39(2) is to disclose without a confidential agreement. In discussion with officials from the public health agency, we came to understand the circumstances where there would be no time for such a confidentiality agreement: In the case of extraordinary, imminent danger. That is really what paragraph 39(1)(b) envisages. We accept that it may not be feasible, and it certainly may not be in accordance with health imperatives, to require a confidentiality agreement before the disclosure in these very specific circumstances.
However, we would like to see, at the very least, shortly after, when the danger to health has been addressed, that a confidentiality agreement be signed with the receiving organization or state to ensure the information disclosed is protected.
The Chair: Could you see that happening within the context of the regulations, or do you feel that a legislative amendment is required?
Ms. Bernier: We feel that a legislative amendment would be preferable. It would benefit the privacy protection regime of the bill.
The Chair: You say there are circumstances where you can understand that, in an emergency, there would not be a confidentiality agreement. If it was done in a legislative form, I assume the wording would have to be along the lines of "unless there is an emergency,'' or something to that effect, that the confidentiality agreement would be provided, or that it would have to be provided a certain number of days after. How would you see that being handled?
Ms. Bernier: We would like to see that subclause 39(2) would provide that, in the case of exchange of information under paragraph 39(1)(b), a confidentiality agreement be signed as soon as possible after the disclosure.
The Chair: On the question of regulation versus legislative amendment, are you saying the legislative amendment is a better way to go, but that it is not impossible under a regulation? Are you saying it that way, or are you saying that is just too weak?
Ms. Bernier: We would prefer that it be in the act.
Senator Segal: First, I want to express my appreciation to the privacy commissioner's office and the officials here for the very constructive back and forth that they have done with the public health agency in sorting out some of these issues. From our perspective, I think it is very helpful to us knowing that the privacy commissioner's office is largely comfortable with where the legislation is now headed.
I want to address the privacy assessment issue as an integral part of the process going forward.
Do you know whether you have standing in a regulatory consultation; do they have to consult you? I note that the head of the agency has indicated no difficulty with choosing to consult you when they go through the regulatory consultation process. However, do you have automatic standing; do you have a right ab initio as part of legislation to be part of that process?
Ms. Bernier: No. In fact, one of the legislative reforms that we would like to see to the Privacy Act is that privacy impact assessments be made mandatory. At the moment, they are not.
Senator Segal: Let me ask you about instrumentality. I do understand why your preference would be legislation. However, if one of the regulations that the government, in its wisdom, chose to draft after consultation said that all of the regulations shall be interpreted within the broad context of the Privacy Act, and the privacy assessment was included as an appendix to this particular legislation, would that give you comfort that you had at least established on a regulatory basis we had done as much as we can, given the government's desperation to get this passed quickly because of some looming disaster which we are just on the cusp of, apparently?
Ms. Bernier: Indeed, it would be more robust. That being said, the Privacy Act does cover the Public Health Agency of Canada. As I said earlier, PIPEDA, which applies to the private sector, also imposes privacy obligations.
Yes, you are right; it would certainly be appreciated. It would reinforce our role.
Senator Segal: Let me take one brief hypothetical. This is quite hypothetical because I would never have had the academic competence to do this. However, I am a biochemistry student working in a lab. This is a stretch; I accept that.
I am in the lab and I am aware of all this legislation; I am aware of privacy concerns. I am also eager to make my supervisor happy because I am working my way through a master's degree or a doctorate. I make an honest mistake handling these pathogens.
In your judgment, do I have any privacy rights here as a student or will I just be trashed and torn apart because some bureaucrat has decided that mistakes are no longer acceptable because they have some risk associated with them?
Ms. Bernier: Everyone has the right to privacy. Therefore, we start from that point. Let us say your employer is a public sector lab. That organization is subject to the implementation of the Privacy Act. The way they deal with your performance issue is absolutely subject to that. Should they contravene your rights, you would file a complaint to us, and we would make a decision.
Senator Segal: Let me also say that I am reassured by the advice you are giving the committee about those concerns, which you had prior to and that have now been worked out, between yourselves and the public health agency. That is very constructive.
The Chair: You should perhaps ask that question about the hypothetical situation when the minister comes, too.
Senator Segal: I think I pressed my luck on that as far as I dared.
Senator Cordy: I would also like to thank you because I had a number of questions concerning the Privacy Act and your role in having a privacy "lens'' in the legislation. You have certainly answered many of those questions in your opening statement.
I would like to go back to one of the points that I am not sure about: The requirement for reasonableness for inspectors, which is subclause 41(2). You feel that that is covered off in subclause 39(2). I am not sure where I see the arc connecting the two of them.
Ms. Bernier: I feel it is covered off in subclause 41(1). Subclause, 41(1), reads:
Subject to section 42, an inspector may, for the purpose of verifying compliance or preventing non-compliance with this Act or the regulations, enter at any reasonable time any place or conveyance in which the inspector believes on reasonable grounds. . . .
Senator Cordy: So, would that cover it?
Ms. Bernier: Our interpretation is that these "reasonable grounds'' apply to subclause 41(2), because subclause 41(2) is, in our view, a description really of the activities envisaged in subclause 41(1).
Senator Cordy: You feel that would cover it off so the inspector would, in fact, have to use reasonable grounds to have an inspection, is that right?
Ms. Bernier: That is our legal interpretation, yes. That is how where he read the provision.
Senator Cordy: There was a point you touched on earlier. We heard from a number of witnesses who were concerned that clause 39, disclosure of information to the minister, might include intellectual property and proprietary information — a patent application — and that, if someone went through access to information, they would be able to get this information. That is what we heard from some witnesses.
Someone corresponded through the clerk to me that they felt that would be solved by adding in paragraph 39(1)(c) the word "health.'' It says ". . .the disclosure is necessary to enable Canada to fulfil its international obligations.'' This person indicated it should, in fact, be ". . .international health obligations.'' That would cover the government in terms of international obligations for epidemics or flus or whatever we happen to have in Canada; they would get the health information. It would protect the disclosure of information for intellectual property that someone may have in a laboratory.
Do you think it would be necessary to have "health'' included? Would people be more comfortable with their personal information stored in that way and have a greater sense that it would not be distributed internationally?
Ms. Bernier: Should the committee choose to do that, Mr. Chair, it would restrict the scope of paragraph 39(1)(c). We have not taken a position on that because we did not feel it was necessary. Certainly, amendments would have to be discussed with the Public Health Agency of Canada to determine whether it would cover the scope they need to fulfill the objective of paragraph 39(1)(c). We do not request that. Obviously, the result would be to narrow the scope and, therefore, the extent of personal information that could be disclosed. That is certainly possible.
Senator Cordy: That would be best asked of the public health officials.
Ms. Bernier: I would recommend that. It is a policy question best answered by them.
[Translation]
Senator Eaton: Thank you for coming and helping us clarify a few points.
[English]
You spoke to paragraph 39(1)(c) and the confidentiality agreement and said that you would like to see an amendment, which would send the bill back to the House. Would a recommendation or an observation satisfy you? How important is this to you?
Ms. Bernier: I was careful in my statement to say that we put this to the consideration of the committee. I must say we are confident that our concerns are not so great that they would necessarily require a legislative amendment.
I said that it would be preferable. It would make the legislative framework more robust. That is a fair description of our position.
Senator Keon: Ms. Bernier, let me compliment you. I believe I have read all of the correspondence between the Office of the Privacy Commissioner and the Public Health Agency of Canada. You are to be highly commended for the way you are working together.
I will ask a difficult question: I served on two of the three major committees post-SARS that resulted in the creation of the Public Health Agency of Canada. At the time, we were aware that Canadians were at tremendous risk because we did not have a database for human pathogens in Canada. The public health agency was in charge of correcting this when they came into being, and they have been working hard. However, the wheels have been turning very slowly. We are in the middle of a pandemic in Canada and we do not know how far it will go. The World Health Organization is predicting a global pandemic this fall. If we want a true infectious disaster in the form of a pandemic, all we need is to have other pathogens lose containment.
There is tremendous urgency in getting this legislation through, and getting the data bank. I will be asking the minister later this afternoon if she cannot accelerate the process for the regulations because I think five years is far too slow, considering the risk to Canadians and the people of the world because pathogens know no borders.
I am convinced that we should move this legislation forward with observations, one of which covers your major concern about 39(2). We should not let this sit over the summer and go back to the House in the fall. God knows when it would be put through and we would have no data bank for maybe another year.
I would like you to tell me if you agree with my thinking. I have studied the bill and the testimony carefully. This is urgent. We are asleep at the switch, as a nation, and we must move this along.
Under the circumstances, should we write a strong observation and look carefully at the regulations as they come under parliamentary scrutiny to ensure that your needs are met? Is it worth delaying this legislation?
The Chair: I will inject at this point. What you say, Senator Keon, is a fair comment. I do not know if it is a fair question. It is a political process that we have to decide on and whether this legislation is ready to go forward as is or should be amended, with the resulting consequence that it could be sitting until the fall. I do not know that it is fair to ask public servants that question. In any event, Ms. Bernier has answered, in effect, by saying that her preference would be to have it all tidied up but they can live with it. Both my question and Senator Eaton's question have been answered. You made fair comment but I do not know that we need to pursue it further as a question.
Ms. Bernier: I would like to reassure Senator Keon that privacy cannot stand in the way of public interest. In fact, the Privacy Act provides specifically for the possibility of disclosure of personal information if it is justified by public interest. Therefore, the circumstances that you envisage could still be dealt with appropriately.
The Chair: We have dealt with that, Senator Keon. Anything more? That is fair comment.
Senator Dyck: Ms. Bernier, your presentation was clear and you are satisfied with most aspects of the bill as it stands.
My question relates to proprietary rights. If I were in a laboratory working on something that had enormous potential for a new treatment for a disease, and then there was an accident in my lab and the inspector came in and seized and copied everything, would I be protected in terms of the intellectual knowledge? Do we have to balance that protection of me as a researcher versus the health of Canadians overall? Do you think that proper balance is there?
Ms. Bernier: The Privacy Act applies to personal information, which relates to an individual in an identifiable fashion. That is the scope of the Privacy Act. It is case by case, but I am not sure it would apply to the scenario that you are putting forward.
Senator Dyck: Might that come under copyright or patent laws or something like that?
Ms. Bernier: Indeed.
Senator Dyck: Then would there be privacy clauses within those laws?
Ms. Bernier: For example, yes.
The Chair: I will ask you another question before I go back to the floor.
Dr. Butler-Jones has provided a fair bit of information on the consultation process over a number of years, actually. Some people have said they felt it was more like briefings as opposed to full consultation, briefings with some Qs and As. How would you characterize the consultation process that you have had and are having at the moment? We might want to consider a recommendation on how this consultation process is held. How do you feel about that in this context in terms of the privacy issues?
Ms. Bernier: Our experience has been favourable and constructive. We have found the public health officials extremely forthcoming, ready to share their information and very thorough in the briefings, to use your words, that they gave us. That being said, they were also receptive to our concerns, and that is how we were able to see actual addressing of our concerns and reconciliation of our points of view. Every time we put forward an issue to them, they satisfactorily explained it. Clearly, they had done their thinking not only from a scientific point of view but from a privacy point of view, and even if we raised issues they had not envisaged, they were open to taking them under consideration. Every time, they came up, as you have been able to see, with a satisfactory solution.
The Chair: Describe how privacy impact assessments work. Is that like an environmental impact assessment on every project, or is it a general table of things or a checklist that you go through every time?
Ms. Bernier: It is a bit of both in the sense that the privacy impact assessment is dictated by the state of the law in Canada as to the protection of privacy rights. It is done by the policy centre, the department that is actually contemplating the program. They produce to us a preliminary privacy impact assessment when it is a pilot, for example, and we review it and work with them. We make comments until we feel they have truly addressed all the privacy issues that would arise from the activity they are contemplating. In the end, we either come to an agreement with the policy centre or not as to their conclusions as to privacy impact assessments.
The Chair: Are you satisfied with the public health agency's response and willingness to engage with you in that process?
Ms. Bernier: We are.
The Chair: Good.
Senator Callbeck: Thank you for coming today. I know you have touched on this, but I want to be clear in my own mind about it. Many people have suggested that the minister has broad powers in the disclosure of information. In your analysis of this legislation, do you think that researchers should be concerned about this bill?
Ms. Bernier: What concern are you envisaging?
Senator Callbeck: In terms of disclosure of information.
Ms. Bernier: That is exactly the way we have approached it. As I said, our concerns have been addressed. It definitely deserved a careful examination from a privacy point of view. However, in our examination, we have found a robust regime to protect personal information through a lot of restrictions, either the use of a reasonable grounds test or the restriction of disclosure in serious situations of imminent danger. Everywhere there is some disclosure of personal information, the bill tightly frames it, so to speak, to ensure it is compatible with privacy rights and the fulfillment of the objectives of the legislation.
Senator Callbeck: So researchers should not be concerned?
Ms. Bernier: From a privacy point of view, we are quite pleased with the protections, the safeguards, provided in this bill.
The Chair: I think we have exhausted this subject. Believe it or not, we are ahead of schedule by 15 minutes, unless you have any closing comments to make, Ms. Bernier. Thank you.
We now give a warm welcome to the Honourable Leona Aglukkaq, Minister of Health. She is here with three people whom we have seen before on this bill, as well as on other occasions.
This is the third meeting in which, minister, we have been dealing with Bill C-11. We have been getting various points of view. If you are familiar with the hearings of the committee on health in the House of Commons, some of those same views have also surfaced here in our previous two meetings.
We are anxious to hear what you have to say about it, and even more anxious to ask you questions based on the evidence we have had at the previous two meetings. We would appreciate your brief remarks and then we will go to questions.
Hon. Leona Aglukkaq, P.C., M.P., Minister of Health: Honourable senators, it is a pleasure for me to meet with you today to address the important issue of the safety and security of human pathogens and toxins.
I would first like to take this opportunity to introduce my officials from the Public Health Agency of Canada, who are also in attendance with me today: Dr. David Butler-Jones, Chief Public Health Officer; Jane Allain, General Counsel; and Dr. Theresa Tam, Director General from the Centre for Emergency Preparedness and Response.
Bill C-11, the Human Pathogens and Toxins Act, has two primary purposes. The first is to enhance public safety by requiring that activites conducted with dangerous human pathogens and toxins be done safely. The second purpose is to establish a new regime of security for dangerous human pathogens and toxins.
Some have questioned the need for enhanced safety, especially for risk group 2 human pathogens. Honourable senators, all human pathogens in risk groups 2, 3 and 4 are dangerous. We face a public safety risk from someone catching a disease in an unsafe laboratory and passing that disease on to the general public.
Some stakeholders have said that there is no risk of this happening, especially with risk group 2 human pathogens. In fact, from 1979 to 2004, there were 15 deaths in North America from infections acquired by persons working with risk group 2 human pathogens. All told, there were 2,156 reported infections acquired by persons working with human pathogens in labs during the same period of time.
While the risk that an infection from a person working in an unsafe lab will spread to the public is small, the potential consequences could be grave.
For example, SARS exists now only in labs in Canada. We need to ensure that deadly pathogens like SARS stay in the lab setting, where they belong. Right now, we have no way of knowing which lab in this country has SARS.
Bill C-11 would enable us to know who is working with agents like SARS, something we do not currently know because there are no requirements to report domestically acquired pathogens. This will allow us to ensure that they are following appropriate biosafety guidelines and the work they are doing is safe.
We need to remain vigilant. We have seen from the H1N1 situation just how fast these infections can spread. What we are asking for is reasonable. Simply put, we want to require that everyone follows the same basic biosafety guidelines when working with human pathogens and toxins.
We also need to address serious security risks. Right now, outside of the federal government, there is no requirement for security screening of persons accessing the most dangerous human pathogens and toxins. Bill C-11 addresses this gap and includes reasonable security requirements. The bill requires that licensed facilities keep a list of persons authorized to have access to their facilities.
Bill C-11 will also allow us to know who has what dangerous human pathogens and toxins in Canada and where they are located. The bill also requires security screening for persons accessing the most dangerous risk group 3, and all risk group 4 human pathogens and selected toxins.
Security screening is a normal requirement in our society where there is a security risk to public health and safety. For example, for years, security screening has been a general requirement for persons working in airports in Canada and in the federal government.
The security risk that we face from human pathogens and toxins is serious enough to justify similar measures and I urge you to support this legislation.
We need this bill, as it provides for a range of important prohibitions at Royal Assent, and includes the basic requirement to take reasonable precautions when dealing with human pathogens and toxins.
Note, however, that nothing we have done in responding to the safety and security risks from human pathogens and toxins was done in a vacuum. We have sought provincial and territorial and stakeholder input into Bill C-11. We conducted sessions across Canada for hundreds of stakeholders from academia to the private sector, and provincial and territorial governments. We have provided regular email updates on the legislation to thousands of stakeholders. We sought the advice of the Privacy Commissioner to help us identify privacy issues that need to be kept in mind as we develop the regulations, and as we develop our privacy impact assessment.
Based on the input we have received from stakeholders, we put forward 10 important amendments to Bill C-11 in the House of Commons Standing Committee on Health. We heard that there should be no security screening for persons in risk group 2 human pathogens. We agreed, and put forward an amendment that eliminates the possibility of security screening for people working with these particular human pathogens and toxins.
Stakeholders also told us to treat facilities with risk group 2 human pathogens less stringently than facilities with risk group 3 or 4 human pathogens or toxins. We agreed, and put forward an amendment that should bring this about.
Stakeholders also asked that advisory committees be established regarding the schedules to the bill. We agreed and supported an opposition amendment to require the creation of such advisory committees.
Some were concerned about the use of the criminal law, and suggested reducing penalties for offences involving risk group 2 human pathogens. We agreed and put forward an amendment to reduce penalties related to these human pathogens.
The Privacy Commissioner wrote to the health committee and made a number of recommendations, especially related to clauses 38 and 39. We met with the Privacy Commissioner and then put forward amendments that addressed her key recommendations. We want to continue to work with the Privacy Commissioner to identify privacy issues that we must keep in mind as we move ahead with consultations on the regulations.
Finally, everyone we met with advised that they wanted to be heavily involved in the development of the regulations. In light of this, we agreed to opposition amendments that will require that regulations be tabled before Parliament. This amendment will enable parliamentarians to ask us about the regulatory consultations to make sure that we involve provinces and territories and interested stakeholders.
We believe that these amendments strengthen the legislation and respond to the concerns of the vast majority of stakeholders.
The Public Health Agency of Canada is committed to engaging provinces and territories and a broad range of stakeholders in the development of the regulations. We recognize the importance of striking the right balance between biosafety and biosecurity and ongoing science and research. We also recognize that some stakeholders will need time to adjust to these new requirements, and we plan to build a reasonable time frame into the regulatory framework to allow them to do so.
Honourable senators, there is a wide degree of consensus on the need for this important legislation. I have been clear on why we need to move forward quickly on this bill. This is an opportunity to improve biosafety and biosecurity in Canada by building on existing guidelines and on our existing importation program. It is also important that we move forward to better protect the health and safety of our citizens.
I am asking for your support in passing this bill so that we can further protect and promote the health and safety of Canadians.
The Chair: Thank you, minister. I will start the questioning and then recognize my colleagues.
On the question of licensing, you said you need to get a handle on what is in these laboratories. I understand that. However, the United States and the United Kingdom — and no one denies that in the United States there are concerns about biosecurity — have not gone this same route. Rather than a licensing regime, they require registration with the appropriate federal authority.
Why licensing as opposed to registration? Much of the concern we had about that came from people who thought that the risk group 2 category was too stringently covered in this. That was a particular concern of theirs. There does not appear to be much of what is in schedule 2 in either the U.S. or the U.K. Many of them asked why we do not spread the laboratory biosafety guidelines further rather than going into the new licensing procedure.
Will you comment on that?
Ms. Aglukkaq: There are three or four questions there. I will begin and then ask my staff if they have anything to add.
In terms of comparisons to the United States and the U.K., for example, the United States has targeted certain pathogens that they think pose the most severe security threats to their citizens. They call that `select agent' in their legislation. The American approach is called the select agent rule. The control of the select agents in the United States is very tight.
To use another example, the British regime, under control of the substances hazardous to health regulations established in 2002, is very similar to Bill C-11 in that it addresses the risk group 2 human pathogens and has the same licensing registration process.
Unlike the American approach, the new act will address both safety and security with respect to all human pathogens from risk groups 2, 3 and 4, as well as the selected toxins, and it will not leave a gap. That is basically why we have gone through this process.
You asked why risk group 2 human pathogens are included in Bill C-11. I mentioned earlier that human pathogens in risk group 2 have been regulated for the last 15 years under the human pathogens importation regulations in Canada. They are dangerous specifically because they are capable of causing serious disease or death in humans. They include the bacteria that causes E. coli, for example. We recognize that risk group 2 human pathogens also pose a lower risk than risk groups 3 or 4. Therefore, the regulatory framework in Bill C-11 will have less stringent requirements for facilities with risk group 2 human pathogens. Again, Bill C-11 was amended in the House of Commons with this in mind.
The Chair: I was focusing on licensing versus registration and using the rest as part of the argument of why people thought registration might have been a better way to go, as they did in the U.S. and U.K.
Dr. Butler-Jones, can you comment on that?
Dr. David Butler-Jones, Chief Public Health Officer, Public Health Agency of Canada: We already have a licensing regime that approximately half the laboratories currently follow. This is modelled after that, so it is basically an extension to currently unlicensed laboratories, because they do not import and export. It really is a familiar process. To introduce a new process would complicate matters for the half of the labs that already have that regime in place. For them, it would be an extension of what they are already doing. It will be new for the new labs, but by going to a different regime you have a new regime for all labs in Canada, not only those that are currently under the legislation.
The Chair: I have a question about the use of the Criminal Code. In cases of biosecurity or bioterrorism where there are deliberate acts to harm the population, one would expect the use of the Criminal Code. What about cases of accident? The chill factor for someone working in a lab of having the Criminal Code held over their head should be considered.
Why were there not administrative monetary penalties instituted for some of these problems rather than criminal penalties? Bill C-6, for example, the Canada Consumer Product Safety Act, has some administrative monetary penalties. There are some parallels. Why would it not have been used in this case where accidents happen?
Dr. Theresa Tam, Director General, Centre for Emergency Preparedness and Response, Public Health Agency of Canada: We examined a whole range of potential regimes in creating this bill. Administrative monetary penalties were not utilized as it has never been part of the current human pathogens importation regulations. Again, as Dr. Butler- Jones said, we wanted to remain as consistent with the existing regime as possible, and that has been administered for many years.
We propose to seek compliance through an ongoing exchange of dialogue with the laboratories to look at best practices. If anything happened, a warning would be issued and a licence may be suspended, if necessary. Criminal sanctions are a last resort.
That was the way we approached it. The ticketing regime and administrative monetary penalties are definitely not consistent with what we currently do. We did not believe that it was reasonable to deduct costs of laboratories on any ongoing basis. Our intention is to have ongoing risk management with these labs. The Criminal Code is a deterrent and something of last resort.
Dr. Butler-Jones: If I might add that we do have 15 years of experience with the Criminal Code in this area. We have not had to resort to that. It is an issue of last resort. Those who are concerned can just look to the laboratories that have been covered by the same for 15 years.
The Chair: Who determines what is last resort? Who determines when that comes into play?
Jane Allain, General Counsel, Health Canada: The main thing we should emphasize is that this law is being enacted under criminal law power. We think it is a regime that meets the thresholds that were set out by the Supreme Court of Canada, and what is needed for our health and safety legislation to be enacted validly under the criminal law power. There are a series of prohibitions and sanctions that can be taken, but there is an accompanying regulatory regime that will accompany the exercise of that function. The point is that there will be compliance mechanisms put into place to ensure that the people who are being licensed and required to fulfill the requirements of the biosafety guidelines will be monitored on an ongoing basis; the inspection power, the warnings, the sending of letters, the standards would be the mechanism by which you would ensure compliance with the act. It is based on the criminal law power, but you do not think of it in the sense of a Criminal Code offence writ large, thou shalt not steal, and if you steal you will get prosecuted. It is basically compliance with the regulatory regime that would allow you to take the proper mechanism.
A prosecutor would have the ultimate discretion, and as Dr. Butler-Jones has indicated, there has never been a prosecution under the human pathogens importation regulations to date.
Dr. Butler-Jones: The decision to take it to a prosecutor would be, in this case, the Chief Public Health Officer. Public health legislation, consistently across the country, it is to that point. It is rarely used, only in last resort, when you have run out of all other options to actually ensure compliance. We have extensive experience with that.
Senator Segal: The last witness was good enough to make reference to people being monitored. Who would monitor whom? How would that monitoring take place and under what authority?
Ms. Allain: I was being more descriptive. It is a licensing requirement. They will have requirements to meet certain conditions as we develop the regulations to obtain a licence. Through that mechanism, they will be monitored through the public health agency for the implementation of that licensing requirement.
Senator Segal: Is it their compliance that is being monitored?
Ms. Allain: Yes.
Senator Segal: It is not them as individuals?
Ms. Allain: No.
Senator Keon: Madam Minister, it is not a good time to be minister, with a pandemic here in Canada and a global one anticipated in the fall.
I followed the progress of this carefully and I am comfortable with the legislation and will be supportive of it. We probably will need some observations to allay the fears of some of the people who testified.
What concerns me more than anything right now, though, is you are being very democratic getting into the regulations. There will have to be legislative approval of the regulations as they come along to both houses of Parliament and so forth. There could be tremendous pressure in this whole area, depending on what rolls out over the next couple of years. Hopefully, nothing really bad will happen but it could.
Could the regulatory process be accelerated without compromising the democratic process that you have outlined in here?
Ms. Aglukkaq: We want to move quickly on the regulatory process. We have committed to consulting a number of stakeholders, and we want to continue that path quickly to get their input as we develop that. It will allow us to demonstrate to the people who have expressed concerns around the regulatory process development to table the reports in the House.
We are trying to do this quickly. We recognize there is a need to respond quickly. When you are dealing with situations like H1N1 or SARS and so on, it is very important to have some standards in place in this country that will allow us to manage and detect dangerous pathogens. It is important to work quickly with the organizations and we will do that.
Senator Keon: In speaking with Dr. David Butler-Jones, my old friend, he has said that this will probably take maybe up to five years. I just wonder whether the democratic process will slow this to the point that regulations you need may not be in place.
Ms. Aglukkaq: We have been consulting for two-and-a-half years on this legislation. Yes, I recognize it is very slow. We have received some feedback from stakeholders that they want to be involved in the development of regulations. Part of getting the support to get the bill through is the need to strike a balance. Personally, I would like to see it done quicker than that in the interests of the health and safety of Canadians. How quickly we can move forward on that, it will take a bit of time to try to balance the two.
You try to build consensus on legislation on a go-forward basis and, at the end of the day, the ultimate goal is to have something in place to protect the health and safety of Canadians. That is basically the position that we have come to in order to move it forward. Perhaps the Senate committee would want to speed that process up and put forth a recommendation to do so. We would be in support of moving that.
Dr. Butler-Jones: While we obviously want to take adequate time to ensure that the regulations are appropriate, that we have done the consultation, the one reassuring thing, assuming the bill passes and is proclaimed, is that labs are then required to report. We then have an involvement with the labs and, even if they are not officially required at that point to meet all the standards because the regulations are not in place, we can work with them to move towards that as quickly as they are able to do so. Even by the time the regulations are in place, we would hope that most of the labs are already in compliance at that point.
As soon as we have this, we will be getting the list of labs. We will start to engage them, and we will start the process of consultation and, hopefully, get to a point where we can actually address it.
In addition, the prohibitions that come in with it mean that, for labs that do create a problem, there is at least some legal engagement. We have an authority to actually go in and engage them directly.
Senator Cordy: Thank you, minister, for coming to sit in front of the committee today and provide us with some information.
I was concerned about the inspectors' right to search and seizure, but we did hear from the officials from the Office of the Privacy Commissioner concerning that earlier.
Once they have seized property, if we look at section 46(3)(a), they have the seized goods and the person whose goods they have seized can apply for restoration of those goods to a provincial judge. The judge can order that the seized item be restored immediately. However, what bothers me is 46(3)(a), on the expiry of 180 days after the day of the seizure.
Six months seems like a really long time for me to have return of seized goods, particularly when it involves someone who is doing research that their research materials are in fact being held for six months. That is a long time.
Ms. Allain: The inspection powers set out in the legislation are ones that we have looked at for other types of regimes that exist for legislation that is health related, such as the Food and Drugs Act or the Hazardous Products Act.
These are to be consistent across federal legislation and are rather standard in terms of procedures. It is a mechanism whereby they can be seized, and the person has a right to go before a court to have that mechanism challenged and, if it is not justified, to have them returned.
These are the types of standard clauses that exist elsewhere.
Senator Cordy: I understand all of that, and I agree with all of that. I agree there are cases in which it should be seized and there are cases where one should be able to go before a court. What I find unusual is the 180 days. When talking about lab work, it seems like a long time.
Dr. Butler-Jones: That is really only in the situation where you have a lab that is acting inappropriately. You do not want them to be able to go back to their research if they have no biosafety and are not managing the materials appropriately, because then you have just returned the risk material to a risky place.
Obviously, if we remedy the situation, it will be back. Again, we have 15 years of experience where that has not been a problem. We are able to work with the lab, with the researchers, whatever, to address any concerns and they have been amenable. If a lab is not amenable to those simple things that would ensure safety, I am not sure I want them to have those materials.
Senator Cordy: I would think in those cases the provincial court judge would not want them to have it either.
Dr. Butler-Jones: Correct.
Senator Cordy: The provincial court judge would not rule that they could get them back, so then it would not matter.
Dr. Butler-Jones: That is true, but it appears to be a fairly standard number, as Ms. Allain was saying. It will be in the application. People will see the concerns when they see it applied. Fortunately, we have 15 years of experience to demonstrate we do not do so capriciously or arbitrarily.
Ms. Allain: The only other point I would underscore is the inspector must release it under section 45 if it meets a certain threshold; if they are satisfied that the act and regulations are being complied with, they must release it. It will only be in circumstances where the inspector has come to a determination that the section-45 threshold has not been met.
Senator Dyck: Good evening, minister. My question revolves around the risk group 2 category, pathogens and toxins. We had witnesses who indicated that they thought they should be removed from the act. They were of the opinion that they were already in their labs, running a safe lab, because they were following the laboratory biosafety guidelines. It relates to that question of why it is necessary to go to licensing as opposed to registration.
Dr. Butler-Jones: Again, it is a consistent regime that we currently already have in place. It has been working well. Those who are comfortable with it and have been using it do not seem to have a problem with it.
Senator Dyck: Some seem to indicate that, under Bill C-11, it would mean more paperwork. They are holding up documents and saying, I already have to apply for this; if I apply for a grant, I have to fill out this form; does it mean I have to fill out another set of forms?
Dr. Butler-Jones: Part of the consultation will focus on how to do this in the most simple and straightforward way possible. In talking to biosafety officers and others who were already meeting the guidelines, those will be minimal because it is good, standard practice.
We will also be working with the provinces. Those which already have some kind of inspection regime do not inspect or deal with the same issues we do, but perhaps we can combine our efforts so it is one administrative process rather than two. We will need to see, through discussions and negotiations, how that actually works. Our intent is to minimize that.
Senator Dyck: I gather then you intend to have a detailed process of consultation with the various provincial ministers of health, as well as the people running research labs and hospital laboratories?
Ms. Aglukkaq: Yes. The other piece to that is to work with labs in a staged implementation of it. It is in our interests to do that, to ensure we have a working relationship, and to ensure they understand the process. It is in our interests, and we are working towards a staged implementation over a certain period of time, in fairness to the organizations that it impacts.
The Chair: One supplementary on this question of consultation. Dr. Butler-Jones gave us some extensive sheets as to the consultation process over a period of time, but some people came in — and I am not touting their cause, I will just tell what they said — and said those consultations were more like briefing sessions with Qs and As as opposed to real, full consultation.
I assume you are telling us you will engage in full consultation, listening to people and their concerns and trying to engage them in a dialogue as opposed to a briefing session.
Dr. Butler-Jones: Absolutely. The irony is we had a series of intensive consultations following the first tabling of the bill. We took that advice, put it into the new bill, including broadening the provisions, not being as restrictive and not being as specific. Then we came to the second consultations and we thought we had addressed those, and it was a surprise to have people say they want them stricter. Previously, they told us they wanted them broader.
Once the bill is passed, we will be able to engage in even more of a dialogue than was available before to get at those. We had a very short period of time, and now we have the time and will take the time we need to actually engage all of those who have an interest in this, particularly our provincial and territorial colleagues, but also the laboratories, universities and others.
[Translation]
Senator Pépin: When she appeared before our committee, Professor Gibson said that she had very strong reservations about Bill C-11, in spite of the amendments it has received since last February. She summarized her concerns with three words: cumbersomeness, cost and criminalization.
I wonder whether you could comment on that. I have been listening to you since the beginning and I think I understand why, but I would appreciate if you could elaborate on that.
Ms. Allain: Regarding the use of criminal power, the Supreme Court stated several times that three criteria had to be met to justify the criminal power of Parliament: that there be a prohibition accompanied by a sanction, and that it be for a valid criminal purpose.
The Supreme Court said several times that there is a scope to this head of power and that may affect a variety of bills.
They stated several times that public health and security are valid purposes which justify the exercise by the federal government of its criminal power.
We believe Bill C-11 respects all criteria and principles stated by the Supreme Court. We were also guided by other pieces of legislation, such as the Tobacco Act, environmental protection acts, the Controlled Drugs and Substances Act, the Food and Drugs Act and the Hazardous Products Act. All these principles have been followed.
The Supreme Court also told us that a very complex regulatory framework could be tied to the exercise of criminal power without defeating it. We think we have met these requirements.
[English]
Ms. Aglukkaq: I will ask Dr. Tam to address the cost issue.
Dr. Tam: We have heard from a number of researchers and others that they are concerned about costs. We have done a benchmarking exercise on what the administrative burden might be to laboratories. Certainly for laboratories, currently following the existing laboratory biosafety guidelines, there should be little impact on the operations stemming from the new act.
We looked at a range of laboratories, and those costs are mainly related to the additional paperwork, for example, that might be required. That mostly relates to some of the potential requirements for paperwork regarding transfers of pathogens, et cetera. We are certainly willing to work again through the consultation process to see how we can be most efficient and effective.
If you are already under the human pathogens importation regulations, that process can be pulled in under the same licensure requirements. If you are already filling in a form for importation, we will not ask you to fill out two forms for domestic and imported pathogens which, for example, can definitely be examined.
For laboratories that are not currently following the laboratory biosafety guidelines, there may be some training requirements, for example. Setting up inventories was a concern in terms of how much it will cost. The majority of labs are level 2 labs, and what we are looking at in terms of consultation is what would be a reasonable inventory. If it is just a list of pathogens and you are telling us that you are not working with anything else other than risk group 2, again, our benchmarking exercise showed that such a listing is of minimal cost.
With respect to the licence itself, we are not asking for any laboratories to pay for the licence. In order to help the labs adjust, maybe there are training requirements. The biosafety officers have been identified for most of the higher- level laboratories already. For the other laboratories, through the period of time for adjustments, we expect the impact on them to be minimized.
We certainly feel that, because we have done some of this benchmarking, the cost implications for the majority of labs will be minimal.
The Chair: The minister has run out of time. I have two more senators down, and we will ask those questions of the officials. Thank you for being with us, Minister Aglukkaq, and good luck.
Ms. Aglukkaq: Thank you very much.
Senator Eaton: Dr. Butler-Jones, last week one of the witnesses was talking about the burden to the diagnostic laboratory system that would reduce patient access, and they would have to upgrade their laboratory facilities for level 2 and level 3 pathogens. He was talking about diagnostic labs where people walk in and have their blood drawn for tests.
Dr. Butler-Jones: We have looked at this from a number of angles and, basically, it does not apply to diagnostic labs. The issue here is not about people walking around with bacteria in them. There are public health regulations in provinces to deal with the issue of people infected. Blood samples, et cetera, are not the issue, and they fall under the normal question of how to dispose of them, et cetera.
This is intended for people growing a virus for the purpose of research or for other purposes such as the development of vaccines or others that are in larger amounts and are a potential threat to the public. It is not about the diagnostic laboratories. Maybe Dr. Tam can speak to the specifics.
Dr. Tam: There is a specific exemption in the bill for people who are collecting samples for the purposes of laboratory diagnostic testing. For physicians, nurses and laboratory technicians who are there just to take a blood sample, there is an exemption in the bill for that. The bill is not there to prevent someone from taking a lab test.
If you are a laboratory that then takes that blood sample and grows the bacteria or the virus in larger amounts, it should be done under the appropriate safety procedures. That, I would hope, is already in place. If it is not, it should be.
The Chair: Let me ask a supplemental to that. You say that the physicians or the lab that collects it are exempt, but what about in the transportation of any human specimen for diagnostic purposes that is going to a lab for analysis? Will any of that be covered or is that all exempt?
Dr. Tam: I can let Ms. Allain talk about the transportation. There are other acts, such as the Transportation of Dangerous Goods Act, which is exempt in this bill.
If you have a diagnostic sample such as water, it is considered, from our perspective, as a natural environment in which this specimen, bacteria or virus is occurring in and is also exempt under this bill.
That blood sample that you have just taken from a patient, or a water sample from an environment from which you have not manipulated and started multiplying the sample, are exempt under the bill.
The Chair: We will not suddenly see delays in people getting the results of their analysis because of some procedure that must be followed under this act?
Dr. Butler-Jones: Absolutely not. It should not interfere at all with diagnostic testing and evaluation.
The Chair: That will come out in the regulations, I take it.
Dr. Butler-Jones: No, it is exempted in the bill. It is also clearly not the intent of the bill to deal with those.
Senator Eaton: Dr. Butler-Jones, you have heard senators this afternoon, and certainly last week many of the witnesses wanted to exempt risk group 2 specimens. My understanding from reading the bill, and please clarify, is that most risk group 2 specimens found in university labs or in big laboratories are already following biosafety guidelines, and the onus is now to find the ones that we do not know about, that have not imported or transported pathogens and toxins from one lab to another. It is really for the protection of the people who work in the lab, and they are very necessary.
Dr. Butler-Jones: There are potentially labs out there with SARS and other viruses and bacteria that would be in risk group 3 as well. You are right; we currently regulate for those who import and export risk group 2, 3 and 4 specimens. They should have no issue with this in terms of addressing it. It is for the protection of the workers as well as public safety.
I described before the example of H2, which was the 1960's pandemic, and anyone born after has no immunity. That was sent around the world by a proficiency-testing group in the United States, and it was labelled as risk level 2. It was only because we knew about the 2 when we discovered that it was H2N2 and not the circulating H3. We were then able to quickly track down the labs that actually had that pathogen and stop it from creating the risk of the next pandemic a little earlier than this one.
Level 2 organisms are very nasty, particularly when you have a lot of them together in one place; they can infect an awful lot of people.
Ms. Allain: I wanted to point out that section 7 basically says no one can conduct certain activities without having a licence, but section 7(2) makes it explicit that it does not apply to any activity that falls under the Transportation of Dangerous Goods Act.
Currently, pathogens are regulated under the Transportation of Dangerous Goods Act, so this act would not apply. You would not need a licence. You have to meet the containment requirements for packaging and sealing when you are actually transporting.
Senator Fairbairn: First, I must admit that I am not particularly scientific. A great many of the questions that have been asked today are ones I had wanted to ask. However, could you draw a picture for me? I am thinking of all the incredible work that is done in this country and how huge the country is — and, here, I am thinking of the far North and rural Canada. Do you have a specific way of connecting with those far-off parts of the country which seem to me to be so different than when you are in an area where there is a larger population that has many scientific places to go, and so on? How do you reach up into the far North and other parts of rural Canada?
Dr. Butler-Jones: If I am hearing your question correctly, this goes well beyond this bill. We anticipate that the laboratories are in the urban centres, by and large. We are not anticipating small labs outside those centres. We see it as a system of public health. This is beyond this particular legislation that, I think, will benefit everyone. It is about local medical officers, public health nurses, inspectors, nutritionists and others, wherever they are working. It is also about being able to be supported, having good practice guidelines and information that allows them to do their prevention and outbreak control work locally, from the province or territory on up.
As an agency, we provide support not only around issues of training, working with universities and others, but also around best practices. We are increasing our capacity in the public health service and placing people out there. In addition, we now have epidemiologists and others working, for example, with the Manitoba and Nunavut situations and the outbreaks there to get a better understanding of the problem.
Senator Fairbairn: That was on my mind when I asked the question in the first place, because those things are happening now, and they are occurring off the beaten track and far away. It is good to hear what you are saying.
Dr. Butler-Jones: Over the last four years, we did a lot of work focusing on the links not only in the system but also internationally. We had someone placed in Beijing who was useful in the melamine incident and with other incidents like H5 and H1. We also have good connections with counterpart organizations, CDCs, centres for disease control and prevention, around the world. That allows us to respond more quickly and to recognize issues as well as to share information. As you saw through H1, the collaboration between us, the Americans and the Mexicans was unprecedented. It allowed us to learn more quickly what we are dealing with and to address it collectively.
Senator Callbeck: Thank you for coming here today. I want to ask a question about the minister's powers of discretion, because it has been raised here with this legislation. As I understand it, a minister can issue a licence, vary the conditions, and suspend or revoke a licence.
If a licence holder has their licence suspended or revoked, they can complain and a committee will review it. The final decision, however, is with the minister. Is that right?
Ms. Allain: That is correct.
Senator Callbeck: What safeguards are here for that licence holder?
Ms. Allain: The minister would only suspend or revoke a licence if there was serious and imminent danger to the health and safety of the public. There are certain thresholds that she must meet before making that determination. The mechanism allows the licence holder as well to make representations with regard to that decision to the minister and to have it considered.
The exercise of the minister's powers under this particular provision would only be exercised if all the other mechanisms that Dr. Tam was referring to had failed. Therefore, if the public health agency, in the administration and the compliance of the regulations, asked the licence holder to meet certain conditions to increase their biosafety measures so that they are in compliance with the laboratory biosafety guidelines, whether on their containment levels or practices, and they continuously fail to do so, it would only be at that time that the minister would be advised and asked to consider taking that step.
Again, it is an incremental approach. It is only at the end when the compliance of the requirements are not being met that the minister would be required to consider suspending or revoking in those circumstances.
Senator Callbeck: If the committee decides otherwise, then the minister's decision still stands.
Ms. Allain: It is the minister's ultimate final decision.
The Chair: Both the original decision-making body but also the appeal body?
Ms. Allain: It is ultimately the minister's decision.
The Chair: Okay.
Senator Cordy: I asked a similar question earlier to the privacy officials who suggested that you would be better able to answer the question. We heard from witnesses who were concerned that clause 39, with its disclosure of information to the minister, may include intellectual property and that would be information in a patent application. If people used the Access to Information Act, they would be able to get these kinds of information.
I had a suggestion of an amendment from one of our witnesses, namely, that instead of subclause 39(1)(c) saying "the disclosure is necessary to enable Canada to fulfill its international obligations,'' that it state "to fulfill its international. . .'' and then the words "health obligations'' would be inserted. That would provide some security for people who are concerned about their proprietary information. The only information that would be given by the minister would deal specifically with health concerns for Canadians and for those living in other countries. Could you comment on that?
Dr. Butler-Jones: I will start and then Ms. Allain may want to supplement. Clearly, the international health regulations apply. However, if there are other international agreements that Canada is required to comply with, and if you only restrict it in one area, then how does Canada comply with those requirements, whatever they might be? Obviously, we are not interested in sharing intellectual property. There are other protections for the inappropriate sharing of personal information which may cover the intellectual property issues as well. I think there are other safeguards in place in the system to do that.
In terms of the licensing regime and the minister's authority, it is a licensing regime. This is an issue of last resort. Beyond the minister's opinion, there is obviously the court of public domain, and so on. That is not an uncommon setting for licensing regimes. I sound like a broken record, but we have 15 years of experience and we have not revoked anyone's licence yet.
Senator Cordy: Could you give me an example of something you would be sharing under this bill that would not be related to health?
Dr. Butler-Jones: There is not anything at the moment. The concern would be that, if Canada entered into an international agreement with which this was in conflict, then that would be a difficulty. Having it remain "international obligations'' allows it, whether it is a health obligation or another obligation, to still meet that commitment.
Ms. Allain: I want to reassure the senators that there are existing provisions to protect confidential business information. Whether or not there is a request under the Access to Information Act, there are provisions that allow us to protect it. It is mainly section 20 of the Access to Information Act which allows to you protect trade secrets of third parties. It would allow you to protect the financial, commercial, scientific or technical information supplied to a government institution by a third party, as well as information the disclosure of which could reasonably be expected to result in financial loss, or gain, on that third party. There are existing protections in the access to information requests that are currently being exercised. When there are access to information requests regarding the existing importation regulations and we have received confidential business information, we still have measures by which we can protect that confidential business information, and we have been protecting that confidential business information from being obtained by a third party.
Senator Cordy: If someone filed an access to information request, what information would they be able to get under the information that the minister will be able to collect under this bill, or would it all be off limits to a media person, for example, who files an access to information request?
Ms. Allain: It does not matter who applies.
Senator Cordy: That would be the example of political life we all look at.
Ms. Allain: We never know who the requester is, although we may know the area they are from. That is part of the principles. There are various provisions we can use, and are required to use, to protect information under the Access to Information Act, as well as the Privacy Act. Therefore, personal information can be protected, as well as confidential business information.
The example I would give is that, under the Food and Drugs Act, there are various submissions that are done to get detailed information from drug companies when they are submitting information. That information can and is protected. It is a similar type of principle. We always look at the request. I do not want to give the impression that we do not look at access to information requests properly and thoroughly. We always look at the requests. We look to see what information we have, and what protections we should be applying with the information that we have under our control.
Dr. Butler-Jones: I have a hard time imagining, in terms of the purpose of the act, that there is anything we would collect that could in any way be jeopardizing to a business in terms of a patent or anything else. This is looking at — What bugs do you have? It is not looking at — Have you done this vaccine in this way, in a certain proprietary sense?
I have a hard time imagining it even being an issue, but there are protections in place.
The Chair: Let me wrap up with a couple of questions.
The Deputy Privacy Commissioner was here, and she said that they are building up a good consultation process and relationship with you and that most of their concerns have been responded to.
They have one outstanding concern, and she phrased it as a preference for an amendment, although they can certainly live with whatever we end up doing here, whether we amend the bill or suggest it as a recommendation. Let me read to you what it is so that I do not get it wrong.
We would draw your attention to subclause 39(2), which relieves the minister of the obligation to have a confidentiality agreement in place before disclosure of personal information, where, as described in 39(1)(b) . . .
While we understand the reason to allow the minister to act quickly in situations of serious and imminent danger, we believe that it would be beneficial to ensure that a written confidentiality agreement is put in place shortly after the disclosure . . .
They prefer to have the confidentiality agreement in place beforehand, and if there is an emergency, immediately after. What do you say to that?
Ms. Tam: This is a point that we have discussed with the Privacy Commissioner. Obviously, we are referring to exigent circumstances, which would be extremely rare. Given that comment, we had indicated to the Privacy Commissioner that we can work with that in practice, and also, if needed, in the development of the regulations. That certainly can be done; however, again, this is related to exigent circumstances only.
The Chair: So you can implement this in the regulation? You can, in effect, implement what they are looking for?
Ms. Tam: Yes, and put it in the actual practice.
The Chair: I have one more question about inspectors. There was some concern expressed by witnesses about the qualification and training of inspectors who get a fair bit of authority here in terms of seizure, et cetera.
Tell us about the qualification and training of inspectors.
Ms. Tam: Again, we have had many years of experience with the human pathogens importation regulations, and we currently inspect laboratories, such as laboratory levels 3 and 4. Currently, the inspectors are well-qualified individuals who are on staff with the Public Health Agency of Canada. We have strict job descriptions for these inspectors, as well as their qualifications.
We will, through the consultation process, look into what other inspectors we can harness in terms of the implementation of the act itself, but these people would be expected to have extremely stringent qualifications as to their abilities to be able to look at compliance with the act and the laboratory biosafety guidelines. In the agency, we probably have one of the only engineering specialists who can inspect laboratories in Canada for their compliance with biosafety procedures.
Dr. Butler-Jones: They do have to have diplomatic skills as well. I do not know if you had anyone from the biosafety world testifying here, but they did testify at committee and were quite complimentary of our inspectors.
The Chair: Thank you. That brings to a conclusion this segment of the meeting. We will now go in camera.
(The committee continued in camera.)