Health Committee on March 24th, 2009

[The Chair, Conservative, Joy Smith]

Good afternoon, ladies and gentlemen.

We are going to be going into another presentation today on Bill C-11. I want to thank the witnesses for coming today. It's very much appreciated.

We have witnesses appearing as individuals. We have Bruce Anderson, senior advisor, occupational and research safety; and Elaine Gibson, professor and associate director, Health Law Institute. Welcome.

We also have Roland Leitner, occupational health and safety consultant; and Raymond Tellier, medical microbiologist and associate professor. Welcome.

From our Public Health Agency of Canada, we have Dr. David Butler-Jones, the Chief Public Health Officer. Welcome, Dr. Jones.

We have Dr. Theresa Tam, director general, Centre for Emergency Preparedness and Response, infectious disease and emergency preparedness branch. Thank you for coming again, Dr. Tam.

And we have, of course, Jane Allain, general counsel for legal services.

As you know, we will ask for presentations from each party and then we'll go into our questions. We'll start with the individuals.

Could we start, please, with Elaine Gibson.

[Elaine Gibson, Professor and Associate Director, Health Law Institute, As an Individual]

Thank you. I have read through the testimony of other witnesses on this bill and I see three themes in particular emerging. First, there's the sense that the bill has not received sufficient consultation with affected communities. Second, there's a concern as to the inclusion of risk group 2. Third, there's the fact that much is being held over to be included in the regulations as opposed to in the legislation and that affected parties should trust that the regulations will be appropriate.

You've been hearing about these concerns primarily from research scientists and lab executives. My comments overlap with theirs, but I'm applying a legal lens to the bill. I'm concerned that aspects of Bill C-11 may be vulnerable to court challenge on the basis of the Constitution, both the division of powers and the Canadian Charter of Rights and Freedoms. I will also discuss the policy question of leaving to regulation significant aspects of the legislation. In each of these areas, I will propose tentative solutions.

On division of powers, the federal government has indicated it is relying primarily on the criminal law power under the Constitution Act to justify entering into a new area of federal jurisdiction. My basic concern is that aspects of this bill may be viewed by the courts as matters of property and civil rights, which fall under provincial jurisdiction. The problems, and I'll deal with each of these in turn, are with overreach, with leaving important matters over to regulation, and with establishing a complex structure that may be viewed as not criminal but regulatory.

First, then, is potential overreach. The full title of Bill C-11 is “An Act to promote safety and security with respect to human pathogens and toxins”. Note that it's aimed both at biosafety and biosecurity. Thus, there are risk groups ranging from 2 to 4, the highest being clearly biosecurity, preventing the substances from being used for purposes of terrorist activity. This is clearly a national security matter and falls comfortably under the federal criminal law power.

As the risk groups go down in level, one might conceive that they are more broadly focusing on biosafety—preventing accidental releases that could cause harm—and less on biosecurity. The greater the focus on biosafety as opposed to security, the more likely that the scheme is intended to regulate labs utilizing these materials and the less it appears to be a criminal measure. The inclusion of risk group 2 human pathogens and toxins, a number of which can be found in our natural environment, tends to look like a matter of provincial jurisdiction.

Second is leaving important matters over to regulation. The Governor in Council under this bill is given very broad regulation-making authority. That's paragraph 66.1(c). Further, very much of how this act is going to operate, how facilities will be licensed and run, what will be the inventory requirements, requirements for security screening, etc., have all been left over to be included in regulations to be drafted at a later date. In fact, Mr. James Gilbert indicated to this committee that the act itself is a shell and the details are to be in the regulations.

In law, the more the heart of the matter is contained in regulations as opposed to in the legislation itself, the more the scheme appears to be regulatory in nature, and thus under provincial property and civil rights powers, and the less it appears to be criminal.

Third is sophistication of the regulatory scheme, and this overlaps with the topic I was just discussing. There's one blanket prohibition in the act and that's on use of schedule 5 human pathogens and toxins. However, primarily, Bill C-11 exempts a whole series of activities from constituting a prohibited activity, assuming certain conditions are met, such as licensing. It gives authority to administer these matters to inspectors, analysts, biological safety officers, etc. This is the third way in which much of the bill appears to be more regulatory, in setting out this complex regulatory scheme, than criminal in its orientation, leading again to the question of whether aspects of the bill fall under provincial jurisdiction.

The three topics I've just identified as giving rise to issues of division of powers...in order to avoid problems with them, I suggest that risk group 2 either be completely removed from the scope of the legislation or restricted to the subject of importation in a separate section, and also that more substance be included in the legislation and not held over to be addressed in regulations.

I urge that the time be taken to sort through the substance of this legislation. I see no reason for haste in this matter and plenty of reason to undertake comprehensive consultations. This is a brand-new field for the federal government in certain respects and the time should be taken to get it right.

Those are my submissions on division of powers. I'll now address policy concerns.

The essence of my concern is that it is not appropriate to leave substantial aspects of the legislation to be decided by regulation. This is separate and apart from the argument I made a minute ago regarding why this leads to questions as to whether the bill is criminal in nature.

The nub of my argument here is that the legislative branch of government should not be delegating authority to the executive branch to define many aspects of the functioning of the scheme. One example of this is that there are risk groups ranging from 2 to 4. We know it's prohibited to handle materials in schedule 5, but for risk groups 2 to 4, there is not a single part of the bill in which the difference as to which risk group applies is identified.

In other words, major aspects of how this bill will work are opaque. This has led many of the witnesses, as well as at least one of the provinces, to express the concern that they're not being told enough about its workings and impact.

Bills receive serious scrutiny prior to becoming law. Indeed, this committee is one of the important protections against there being bad laws enacted. Further, there is the scrutiny of the public as reflected in debates of the House of Commons and Senate. On the other hand, regulations are enacted by the Governor in Council, meaning essentially that cabinet gets to decide what is in regulations.

The ease with which regulations can be enacted, varied, and annulled at the whim of the government of the day should sound a major note of caution to the committee. These matters should be in the legislation itself.

In terms of solution, the same solution as in paragraph (a), the division of powers, is suggested; that is, hold consultations with the communities of interest and then develop a bill that includes its full substance, leaving merely the administrative matters to be dealt with in the regulations.

Next, and finally, there is the Canadian Charter of Rights and Freedoms. The charter limits the discretion of the government in that it grants persons rights against certain actions of government. If legislation intrudes on these rights in a manner not justified in a free and democratic society, it may be struck down as being of no force or effect. Thus, it is important that the bill in its entirety not violate the charter. In particular, I'm concerned about the right to be protected against unreasonable search and seizure under section 8 of the charter.

Privacy is a protected right under the charter in a variety of contexts, notably the right against unreasonable search and seizure in section 8 of the charter. Clause 38 of this bill grants the minister very broad powers to compel the supplying of personal information that, in his or her opinion, is required. Note that there's no requirement for reasonableness. The minister, in turn, is entitled under clause 39 to disclose this information without consent to a wide range of parties, including to foreign governments, for a wide range of purposes.

Clause 41 allocates similarly broad powers to inspectors to search places or conveyances and to seize materials found there. None of this is on the grounds of reasonableness in terms of requiring the information or materials. Further, there is no confidentiality clause in Bill C-11.

I propose that these powers be more closely circumscribed. The bill should identify in much greater detail the specific types of information the minister may compel and the purposes for which the information can be utilized, including the disclosure abilities. It should also indicate that the least amount of information in the most de-identified form necessary for the purpose be collected, used, or disclosed.

Further, the requirement of reasonableness in the compelling of information should be incorporated. The more criminal in nature the activity under review, the higher the requirement that there be a reasonableness component. It's important that the powers of search and seizure, or at minimum the more intrusive powers of search and seizure outlined, be exercised on grounds of reasonable suspicion.

[The Chair, Conservative, Joy Smith]

Ms. Gibson, I just want to say that you're almost at 10 minutes. Go ahead, just to finish.

[Elaine Gibson]

I have maybe three more sentences.

Wording should be added to this effect. Also, a confidentiality clause should be added to the bill that outlines broadly a duty on all parties to keep personal information confidential, subject to other provisions in the bill.

I note that the federal Privacy Commissioner, in a letter to the committee, has expressed a number of concerns and the need for further consultation, including a privacy impact assessment. I concur with her comments.

Thank you.

[The Chair, Conservative, Joy Smith]

Thank you very much, Ms. Gibson.

Now we'll go to Roland Leitner.

[Roland Leitner, Occupational Health and Safety Consultant, As an Individual]

Thank you very much for having me here today.

I did not prepare extensive briefing notes as my colleague did, but I would like to tell a little bit of my story.

I was hired by the University of Calgary over 23 years ago. I became a biological safety officer shortly thereafter. When I started working for the University of Calgary, the issue of biological safety was non-existent. We had researchers working throughout the university with materials. The university, which was somewhat responsible for what was happening in its facilities, did not know who was working with those materials, where they were working with them, or what those people were working with. In other words, the university was in no position in any way to know what was going on or in any way to try to contain it.

Over the past 23 years I have been successful in introducing a system that allows the university to know what is being worked with, where it is being worked with, and so forth. Initially the response from researchers was that because they were microbiologists, they knew what they were doing, and therefore there was no need for regulation and no need for any guidance whatsoever. I found in the meantime that this was more bravado than actual knowledge of how to work with biohazardous materials.

It reminded me, in retrospect, of the introduction of nuclear substances into research programs. In these situations researchers were using nuclear substances as tools to achieve certain outcomes without having any background on the work. That is even more the case nowadays; a lot of biohazardous materials are used as tools to establish certain outcomes without any knowledge or background on the part of the researchers on the potential hazards of those materials.

When the importation legislation referring to laboratory biosafety guidelines came in some time ago, for the first time we had an inkling of what such regulated work with biological materials would look like. Many of our laboratories are level 2 laboratories. One problem researchers had was to understand that containment level 2 laboratories do not need as much in terms of requirements as they would originally say they would need. There was a preconception that any work they did with level 2 materials required expensive equipment, which is simply not true.

The situation that has existed from the time we had the importation legislation up until now is similar to requiring only the drivers of vehicles that are imported into Canada to have insurance, to have a licence plate, and to follow the rules of the road, while no one else has to meet those requirements at all.

My university is in full support of this legislation. We'd like to get a clear picture of what it looks like. Let me assure you that in times of financial restraint of the kind we are going through right now, it is the issues that are legislated that receive the attention of people at universities and other institutions. There's a good case to be made that anything that works with nuclear substances is going to be addressed and anything that is regulated is going to be addressed, but biological safety is not being legislated to that degree and would not be addressed to that extent.

Thank you very much.

[The Chair, Conservative, Joy Smith]

Thank you so much.

We'll now go to Raymond Tellier.

[Dr. Raymond Tellier, Medical Microbiologist, Associate Professor, As an Individual]

Thank you very much, and thank you for the invitation.

I don't have a very extensive presentation, but I have a few comments, nonetheless. I came here more prepared to answer questions.

I'm a medical microbiologist, and I spend a considerable part of my time working in diagnostic microbiology laboratories, so my reading of the bill has been very much coloured by that experience.

I think legislation that clarifies these issues and provides clear regulation and has the tools to enforce them is something that is welcomed overall. However, we ought to be cognizant that this legislation is proposed in the Criminal Code, which has very broad power, and if it is not done right, it's going to cause considerable problems.

It may cause a definite chill in the scientific community, especially in light of recent events in the microbiology community in the United States following the legislation of biosafety and biosecurity they have introduced--I'd be happy to go into the details on that. I think we can agree that it's important to do it right.

Personally, I was very much comforted during the consultation we had with the civil servants and the PHAC and other agencies in which they indicated they very much want to continue their historical approach, which has been one of cooperation and education rather than coercion, but to nonetheless have the tools available in cases where it is necessary. I must say that having seen the proposed changes and the changes in the law that has followed the consultation, I'm very much encouraged in that regard.

It is important to realize that the danger of legislation that is too strict is an inhibition or paralysis of diagnostic microbiology laboratories, which would have important adverse effects on the health of Canadians being treated in the hospital. Not only are many Canadians hospitalized primarily for infections, but infections are one of the most common complications of many of the other therapies we have, be it organ transplantation, cancer treatment, surgery, etc. It is very important for public health, and for the health of Canadians, that the diagnostic microbiology laboratories be able to do their work.

With respect to a few notes that I made on the bill, the clarification that many of the regulations concerning the handling of risk 3 and 4 pathogens, or even risk 2 pathogens, does not apply to natural samples such as a human patient actually infected with the disease or samples that are taken for laboratory testing is very much welcome.

I think there are problems with the schedules that list the organisms. They have been improved throughout the process, but they still contain mistakes and many surprising omissions. Even if they were perfect at this point, it is the nature of the field that this list must be regularly updated because of changes in our knowledge or changes in the objective circumstances. It is important that the schedules be updated easily and that they not be cast in stone.

I don't know all the technicalities of overlap of jurisdiction, but I was also concerned about the licensing issues for diagnostic laboratories. There are already licensing processes at the provincial level that are in place. Speaking as a very busy laboratorian whose resources have been cut over the years, it would be very welcome if these processes could be synchronized so we could do licensing at one time in the year and not spend our time moving from one licensing process to the other.

I think the revised licensing for risk group 2 pathogens has been considerably streamlined, and it's very encouraging in that regard.

There is a lot of concern among all of us about the inspectors. They will apparently carry considerable power, and we are a little concerned about their scientific background and training, and making sure their powers are used judiciously.

From the point of view of diagnostic laboratories, I am concerned about the power inspectors have to make copies of any records. In diagnostic labs many records contain names of patients, what the samples are, and what they have been tested for. You can well imagine that you'd like to keep some micro-organisms more private than others. But whatever is the case, there is very stringent privacy protection legislation that we have to obey in diagnostic laboratories, and it seems to me there's a conflict there.

That's all I have to say for now. I came mostly prepared to entertain questions rather than give an extensive presentation.

[The Chair, Conservative, Joy Smith]

Thank you very much.

Dr. Butler-Jones.

[Dr. David Butler-Jones, Chief Public Health Officer, Public Health Agency of Canada]

I'll be very brief because we want to leave this opportunity mostly for questions. I will ask Jane to speak to the legal points. I'm obviously not a lawyer, and that's probably a good thing.

On the issues of privacy, etc., we are clearly subject to that. The list of pathogens is illustrative. It is not intended to be either exhaustive or represent what would be included in the regulations, which require broad consultation. That's part of the reason why the legislation is so broad. In the consultations we were told that a number of things really need more specific direction. They need to be in the regulations rather than the legislation so they can be modified to respond to the changing science.

I'm going to leave it at that. I think Jane should speak to some of the legal points that have been raised.

Back to you, Madam.

[The Chair, Conservative, Joy Smith]

Ms. Allain.

[Jane Allain, General Counsel, Legal Services, Public Health Agency of Canada]

Hello.

Well, the first thing I want to underscore is that, as you probably no doubt know, health is not a distinct head of power enumerated in our Constitution Act, and essentially you have to look at other heads of power to see how it fits in. There are several heads of power that support federal legislation in relation to health. Ms. Gibson is correct that we are primarily relying on our criminal law power for Parliament to enact Bill C-11.

Criminal law power used by Parliament can be valid health-related legislation provided that it addresses a valid criminal law purpose, such as the protection of public health. We believe that Bill C-11 does so by trying to criminalize certain behaviours dealing with human pathogens and toxins. It's backed by both a prohibition and a penalty. And Bill C-11 does have various prohibitions in clauses 6, 7, and 8 of its statute, and the penalties are set out in clauses 53 to 58.

Parliament has used criminal law power to enact various legislation that is somewhat similar in the way this specific bill is designed, and these various pieces of legislation have been supported and upheld by the Supreme Court of Canada. The Canadian Environmental Protection Act is an example, as well as the Food and Drugs Act, the Controlled Drugs and Substances Act, and the tobacco products control act.

The other thing I would like to underscore as well is that the penalties found in Bill C-11 are quite similar in scope to others that we received and modelled against, to a certain extent, such as the Quarantine Act and the Canadian Environmental Protection Act.

With regard to the charter provisions, the Minister of Justice has the responsibility under section 4.1 of the Department of Justice Act to always ensure that bills that are tabled in Parliament have had a charter review. As a result, when the Department of Justice looks at legislation as our clients are developing them through the policy development as well as the actual drafting, we do look at those provisions and ensure that it's charter compliant. We look at things like the search and seizure provisions to ensure they are compliant with section 8 of the charter. I can assure you that such a review was done by the Department of Justice for this piece of legislation, and in fact the inspection powers are quite similar to other pieces of legislation that currently exist, whether it's the Hazardous Products Act or the Quarantine Act.

With regard to the privacy concerns, the other aspect I wanted to underscore is that the agency is still bound by the Privacy Act and the requirements that are imposed by the Privacy Act, which, as I mentioned before, include the minimal collection as well as the minimal disclosure principles, and the department will have to comply with those provisions as it develops its regulations. In fact, for the disclosure of documentation to a foreign body, there is a requirement to get written assurances that they will maintain the confidentiality of that information. So that protection does exist in this legislation.

Those were the main points I wanted to underscore on the constitutional aspects as well as the charter.

With regard to the Governor in Council making regulations, it is in fact a delegation from Parliament to the executive, as Ms. Gibson has indicated. But I would not say it's done in secrecy. In fact, there is quite an extensive requirement for the department to go out and consult, to prepublish their regulations as they will be developing them, and then to reply back in terms of the consultation process. That's in the Canadian gazetting process, and the department has indicated quite clearly that it intends to follow that model.

[The Chair, Conservative, Joy Smith]

Thank you.

Dr. Tam, did you want to make any comment?

[Dr. Theresa Tam, Director General, Centre for Emergency Preparedness and Response, Infectious Disease and Emergency Preparedness Branch, Public Health Agency of Canada]

No.

[The Chair, Conservative, Joy Smith]

Okay. We'll go directly to the questions. The first round is seven minutes for the question and answer. We'll begin with Dr. Bennett.

[Carolyn Bennett, Liberal, St. Paul's, ON]

Thank you very much.

Ms. Gibson, I found your testimony very thoughtful, and I thank you for having read all of the other testimony and summarized for us. I think you summarized very closely to what a lot of us have been concerned about. We take the responsibility of the committee to get this bill right.

I guess my first question is on the proposal that the government will show us their proposed amendments tomorrow afternoon and then we would vote on clause-by-clause on Thursday afternoon.

Do you think this committee would have done its job properly if we agree to go to clause-by-clause on Thursday afternoon?

[Elaine Gibson]

In the evidence of the witnesses so far, I haven't heard a compelling argument as to why this bill should not be put on hold and that consultations happen and the legislation made much more complete. I have not heard a pressing need to proceed quickly with this bill.

[Carolyn Bennett, Liberal, St. Paul's, ON]

Certainly, that is my feeling. There were many concerns, and the amendments are supposed to remedy those concerns. I would feel better going back to the people who expressed the concerns to find out whether the amendments fix them.

I was also concerned to read the summary of sessions with stakeholders, and to see reiterated the difference between information sessions and consultation. A lot of the concerns that were raised by the witnesses are clearly here in the stakeholder summary, but they are not fixed in the bill. The response from the Public Health Agency of Canada said the legislation would provide clear definitions, but it doesn't. When people asked how they'd know whether their concerns were reflected in the bill, the Public Health Agency said this would come out in their consultation strategy.

Here it says that people who've been in the country for ten years won't be cleared. For all the laboratories, clearances should be good for five years. Students could perhaps work without a student security clearance if a supervisor were authorized.

As a legislator, I find it hard to trust that all this will be fixed in the regs. They tell us not to worry, that they'll fix it in the regs. We also have the situation with the Assisted Human Reproduction Act, where we specified that the regs would have to come back to this committee. We've only ever seen one chapter, and the whole thing has been on hold.

PHAC responds that there is no policy intention to capture non-pathogenic agents. If non-pathogenics are eventually captured, schedules could be changed by ministerial regulation. That is what everybody is hugely worried about. With respect to polio, they say it's not in the schedule, but, when banned worldwide like smallpox, it will go in schedule 5 of the bill. It's 2009. I don't understand how you can leave out polio.

I am asking the department what they have to say about Ms. Gibson's serious concerns. What's the hurry, and why can't we just get this right? Why can't we put what must be in the bill, in the bill? Why can't we send to regulations only those things that need to be flexible?

[Dr. David Butler-Jones]

As a result of the consultations on the previous bill, which was more specific on a number of these items, we were requested to make this one less specific. The view was that with the changing science it would be better to have the act in place and then work through an intensive, clarifying consultation on the regulations. This act responded to that view. Now some people think it should be more specific—when we were responding to a request to make it less so.

As to the specific clarifications and amendments required to address the concerns that people have raised, that's a legislator's decision. But that's how we got to this point. It was in fact an honest response to the consultations, and it was drafted so as to recognize the request from scientists and others to make it less specific. Now we're back on the other track.

The issues that have been raised are not new. It's just that we feel we can address them through the regulation, which is a public, transparent process. We want to make sure that we get the application of this right at the end of the day.

Thank you.

[The Chair, Conservative, Joy Smith]

Ms. Allain, would you like to make a comment?

[Jane Allain]

The main point that Dr. Butler-Jones was referring to was with regard to the scheduling of the pathogenic material. Through the consultation, initially, it could have been a Governor in Council scheduling amendment, but we reflected the changes so that the minister, through expert advice, would now be able to change the schedules. It allows that flexibility and adaptability, because if you do a Governor in Council regulation as opposed to a ministerial regulation, it's more onerous. That was the main point that Dr. Butler-Jones was making.

[Dr. David Butler-Jones]

As well as the difference between level 2s, 3s, and 4s.

[The Chair, Conservative, Joy Smith]

Thank you very much, Dr. Butler-Jones and Ms. Allain.

Monsieur Malo.

[Luc Malo, Bloc, Verchères—Les Patriotes, QC]

Once again, I would like to thank our witnesses for being with us today. New witnesses always enrich our discussion of issues, and I thank you for that.

Ms. Gibson, you said since the federal government is getting into a new field under Bill C-11, it would be much more reasonable, in order to comply with the Constitution and the Charter, to limit the scope of Bill C-11 with respect to group 2, and that more items be included in the legislation, rather than in the regulations. If the opposite were done, there would no doubt be some court challenges to the bill's constitutionality.

For her part, Ms. Allain, from the agency, seemed to say that there was a consultation process and that areas of jurisdiction under the Constitution will be respected.

Just listening to you, I see a constitutional battle looming, because the two viewpoints are at odds.

I would ask you each to present your arguments again and explain the reasons for them.

[The Chair, Conservative, Joy Smith]

Ms. Gibson.