Health Committee on March 24th, 2009

[Elaine Gibson]

I am not saying with certainty, and I would be foolish to say with certainty, that this bill is unconstitutional, so please don't misread me on that. I'm raising some concerns about its constitutionality, both on division of powers and on charter grounds. The charter argument is more limited, and it has to do with the powers of search and seizure and the powers of compelling personal information in the statute. I believe they are overly broad and that the reasonableness standard needs to be incorporated.

Did you receive a copy of the submission of the federal Privacy Commissioner? Okay. Some of my concerns are also elaborated upon by her. So that's the charter portion that I was addressing.

When it comes to division of powers, there's a case out of Quebec that overturns the majority of the Assisted Human Reproduction Act on the basis of division of powers. It's a Quebec Court of Appeal judgment. It's being heard before the Supreme Court of Canada, so the law is quite unsettled. If you look at that case, you will see that the types of activities are very similar.

The claim of the federal government was to justify it under the criminal law power, and the Quebec Court of Appeal says they don't find that significant portions of it fall under the criminal law power, that in fact the prohibition sections certainly do, as well as some others, but the broad licensing scheme does not look like what they referred to as an evil that needs to be addressed, and that in fact assisted human reproduction is something we want to promote. That is very similar to the use of laboratories' use of these substances, and the licensing and inspection procedures, etc., are very similar to what happened under the Assisted Human Reproduction Act.

We don't know yet what the Supreme Court of Canada will say on this. They do tend to give very broad discretion to what can be found to fall under criminal law power. On the other hand, this decision will be coming sometime in the next year, presumably, and we'll have much more guidance. For the moment, we know that the Quebec Court of Appeal says that a scheme very similar to this one, with all its licensing provisions, is unconstitutional in terms of division of powers.

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

As I understand it, there may be lawyers fighting over this in court, rather than parliamentarians reviewing the bill, because there are—

[The Chair, Conservative, Joy Smith]

Monsieur Malo, would you be so kind? I didn't notice Dr. Butler-Jones--

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

Go ahead.

[The Chair, Conservative, Joy Smith]

Is that okay? Thank you.

[Dr. David Butler-Jones]

I had a conversation with [Editor's Note: Inaudible] in private. He now seems to assess the program favourably. That is the best place for this, if the reasonableness test is met. The provisions in this bill are also found in existing legislation in Canada.

Ms. Allain.

[Jane Allain]

As Ms. Gibson said, the Assisted Human Reproduction Act is before the Supreme Court of Canada. The Government of Canada is firmly convinced that it is constitutional, and that the ruling by the Quebec Court of Appeal is not in keeping with the Supreme Court's case law as to what Parliament can do with respect to its criminal law power. We believe that the full text of all bills of this type, which contain criminal sanctions and prohibitions, must always be reviewed.

The problem is that in making its ruling, the Court of Appeal deciphered and dissected the bill. We think this is the wrong approach, one that has not been supported by the Supreme Court of Canada to date. We feel sure we will win the case before the Supreme Court of Canada, as we usually do, but I do not want to argue that case here.

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

Is the objective to send legislation to the court and go as far as possible so that you always get a little more?

[Jane Allain]

No. The objective is to legislate in an area in which Parliament has been able to legislate to date and to do it in the appropriate manner. We always conduct an exhaustive analysis—and I can certainly confirm that—with our colleagues in the department.

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

In that case, if the provinces—

[The Chair, Conservative, Joy Smith]

Thank you, Mr. Malo.

Ms. Wasylycia-Leis.

[Judy Wasylycia-Leis, NDP, Winnipeg North, MB]

Thank you, Madam Chairperson, and thanks to all of you.

I want to break this down into four areas, which I think we have heard are major concerns, and ask the non-departmental health officials to respond first. Then I'll ask Mr. Butler-Jones and Theresa and Jane to respond.

The first has to do with the concern that this bill is so focused on biosecurity that it is indiscriminate in terms of the types of pathogens and toxins we're dealing with and therefore will hamper research in this country. We've heard that over and over again. The last reference that we had was to what happened in the United States under legislation similar to the Patriot Act. In that case, researchers have decided to discontinue or not pursue research on regulated biological agents rather than implementing the new security regulations and bearing the associated financial burden.

That's my first question.

Do the witnesses have a comment on that aspect, and do the Health Canada and public health officials have a response to those concerns?

[The Chair, Conservative, Joy Smith]

Dr. Butler-Jones, or Mr. Tellier, were you first? Go ahead, Mr. Tellier.

[Dr. Raymond Tellier]

This is certainly a concern that is raised by the legislation. It's a little difficult to address it completely until we see the regulations, but I agree with you that a danger of such a bill is that with indiscriminate use it can result in a chilling effect on medical research, on diagnostic activity, and it can result in injustice. Unfortunately, these things have happened in the United States, where the effect of the Patriot Act has been an exodus of research on organisms that are on the special organism list in this legislation because many researchers see it as not worth the trouble and the danger of inadvertently being found in infraction. There is the case of a distinguished microbiologist, Dr. Butler, who ran afoul of one of the provisions of the Patriot Act, which he himself reported. The consequences were very severe in terms of imprisonment and loss of his medical licence and position at the university. Yes, there is a concern.

At the same time, if this legislation is done correctly, if a clarification is done that could be beneficial, I think that certainly for risk group 2, which is the immense majority of the micro-organisms being handled in diagnostic laboratories and in research, the evolution of the consultation seems to me to be moving in the right direction.

Risk group 4 is handled only at the international microbiology laboratory in Winnipeg, so the federal government can regulate itself to its heart's content, I would think.

Risk group 3 is perhaps where we'll have the most problems because several organisms in there are very dangerous. That's why they're there. They need to be regulated correctly. At the same time, the laboratories of level 3 are becoming more and more common for both research and diagnostic purposes. We need only to remember that over the past few years Canada has seen major outbreaks with level 3 organisms: the SARS epidemic in Toronto and Vancouver, and the introduction in North America, including Canada, of the West Nile virus. Both of these viruses are risk group 3.

Also, something that is not addressed specifically in the legislation but is being seen considerably in research is the use of viral vectors with genetic construction that could, in theory, cause cancer, and these are to be handled in level 3 laboratories. So what we have been seeing over the past several years is an increase in the number of level 3 laboratories in the country, which overall is a good thing because they do respond to a need, but they have to be operated properly in both senses of the word. You must not end this work that needs to be done for medical research and for public health, but at the same time we have to be sure no reckless work that could pose danger is being done.

[The Chair, Conservative, Joy Smith]

Would anyone else like to comment?

Ms. Gibson.

[Elaine Gibson]

Just very briefly, health researchers in Canada took a hit in the last federal budget, so already there is a concern that some of them may leave Canada for greener sites for conducting research. The concern about the increased cost to researchers is a valid concern. We're being told this will be dealt with in the regulations, but we don't have enough information on that at the moment.

[The Chair, Conservative, Joy Smith]

Ms. Wasylycia-Leis.

[Judy Wasylycia-Leis, NDP, Winnipeg North, MB]

I want to go now to David Butler-Jones and Theresa Tam about this particular issue because they have heard it before. We've talked about how we can separate level 2 pathogens. Can you make a proposal at this time?

[Dr. David Butler-Jones]

Certainly through the regulations the intent is that for security clearance it would not apply to level 2. It would not even apply to all level 3 pathogens.

I'll turn it to Theresa just to mix it up a little bit.

[Judy Wasylycia-Leis, NDP, Winnipeg North, MB]

While you are answering that, could you answer whether or not you are contemplating anything in the legislation that would help clarify this so that we don't have to trust that the regulations will clarify the issue?

[Dr. Theresa Tam]

The Public Health Agency is receptive to clarifications or assurances that we will treat risk group 2 differently from risk groups 3 and 4. We certainly agree that there has to be a degree of flexibility for risk group 3 so that in the regulations and through consultations we can distinguish those of high lethality and impact versus TB or HIV or others in risk group 3 that could essentially be handled differently.

We do want to take a measured approach to risk group 3. It is meant to be risk based.

I just want to reiterate that the legislation is a made-in-Canada solution built upon our existing laboratory safety guidelines, and those distinguish very clearly the differences between risk group 2 and groups 3 and 4.

Then I think the laboratories were concerned about the security aspects and the added burden as a result of that. We did include wording in the current legislation that indicates a security clearance for select pathogens and toxins. It gives consideration to flexibility on risk group 3. Again, the agency is receptive to proposals in terms of more specificity or clarification around that point.

The bill actually does indicate that those who don't have a security clearance can be supervised by those who have. That is currently included in the wording of the bill.

I think the cost, especially in these current economic times, is a concern. Through the regulation and program development process we envisage a reasonable timeline. While we cannot predict what the economic climate will be in five years' time, we would want to approach the implementation in such a way that we can actually take into account the circumstances and the context in which laboratories are working so that they will have time to adjust to certain requirements.

[The Chair, Conservative, Joy Smith]

Thank you, Dr. Tam.

I believe, Mr. Leitner, you want to make a few comments. Then we'll go to Dr. Carrie.

[Roland Leitner]

Very briefly, our university operates one containment level 3 laboratory that works with various agents that are on the international list of warfare agents. Some, if not the majority, of research with those agents even in Canada is funded through the United States Army Medical Research Institute of Infectious Diseases.

As such, our laboratory has to, and has had to, comply not only with Canadian requirements but also with the requirements of the legislation that you brought up, the Patriot Act. As such, we've had to provide security clearances for the people who access that laboratory. My experience was that it was a very fast process. The process didn't cost us anything other than a little bit of delay. It certainly did not turn out to be as onerous as was originally anticipated by the laboratory.

This is certainly something that some of the laboratories in Canada already comply with if they work with those agents, and it is far less onerous than other people have been led to believe.

Thank you.

[The Chair, Conservative, Joy Smith]

Dr. Carrie.

[Colin Carrie, Conservative, Oshawa, ON]

Thank you very much, Madam Chair. I want to thank the witnesses for being here today.

I'd like to talk about the issue of consultation for a couple of moments, Dr. Butler-Jones. I have taken a look at the four years that you did work on different consultations; some people called them information sessions. I think Dr. Tellier and Dr. Leitner said they were consulted in the process. There has been talk in the committee about provincial and territorial consultations. I know we got a copy of a letter from British Columbia.

I was wondering if you could comment. Have you been in contact with British Columbia? Was there a difference between the political content of the letter as opposed to that from government officials in your conversations or communications and consultations with B.C.? Was the letter we got dated, and is it common to date those?