Bill C-11 (Historical)

Human Pathogens and Toxins Act

An Act to promote safety and security with respect to human pathogens and toxins

This enactment creates measures to promote safety and security with respect to human pathogens and toxins and all activities associated with them. It establishes a comprehensive legislative regime that extends beyond the present importation regime. It requires every person conducting activities involving human pathogens or toxins to take all reasonable measures to protect the health and safety of the public.

Motions in Amendment

[Joyce Murray, Liberal, Vancouver Quadra, BC]

Madam Speaker, I am pleased to make comments on Bill C-11, having been part of the committee and the process of reviewing the bill, identifying the strengths and weaknesses of it and taking action, as my Liberal colleagues and other committee members did, in what was, in the end, a very co-operative process.

Everyone in the committee was in accord about the importance of ensuring that the handling of pathogens and toxins in laboratory work and transportation of these goods protect the individual safety and public safety.

We did ascertain that there were risks with some of those products, greater risks with some than with others, and that the public good was best served by laws addressing that. Therefore, there was a common view that this was the right thing and a good thing to do.

My experience as a legislator tells me that the public good is sometimes served by laws addressing a problem, but government always needs to be very aware that there are risks arising from possible unintended consequences of the legislation being proposed.

Pretty classic risks of unintended consequences include things as: stepping into the jurisdiction of another level of government; duplicating existing work and licensing and processes already in place to protect the public; placing a regulatory burden that would be onerous given the benefits; the impacts on the delivery of a public good that we are trying to promote may reduce the delivery of that public good; stepping into information privacy terrain and risking the disclosure of personal and private information that is inappropriate or against the law; or even using, in effect, a sledgehammer to crush a flea by having very onerous provisions and penalties in situations where they are simply not warranted.

Those are classic potential downsides or pitfalls to making laws. I think all legislators would agree that we need to be mindful that we are not over-regulating and we are not creating more problems than we are solving just for the pure joy of addressing problems and making laws.

When the bill was first presented to the committee, there were very severe concerns and, in fact, those concerns fit into that whole range of unintended negative consequences, which I outlined as theoretical ones. They were in fact present in Bill C-11.

Why was a bill, which had so many problems, being pushed through for fast approval at committee? What was clear was the consultation the government should have done with respect to writing the bill to address the risks around the handling of toxins and pathogens had been completely inadequate. Although the committee members were assured that there had been extensive and adequate consultation, when the list of those activities was reviewed, it was clear that there was minimal consultation with the decision-makers in the province of British Columbia. I know some of the other provincial health officers had the same concerns.

A letter from the minister of healthy living and sport in British Columbia, for example, had very strong language of concern about Bill C-11 as it was first presented to the committee, words such as, “The schedules are over-reaching”, “The administrative burden of regulation is felt to be onerous”, and “it is our strong preference that a new bill be considered which is collaboratively developed through consultations with the provinces and territories”.

This is a strong indication that adequate consultation did not occur. The absolute foundation of good legislation, legislation that previews and corrects unintended consequences, is to talk to the very organizations and individuals affected by it. This has been consistent problem with the Conservative government.

I was very involved when Bill C-51 on natural products was brought forward last year. It infuriated organizations because they had been completely left out of the consultation process. Had they been involved, they would have made very constructive representations as to how to improve the bill. The bill was killed when the House, when the Conservative government called an election last September. We will see whether the necessary improvements have been made.

With Bill C-11, several provincial governments felt it was completely inappropriate to step into their jurisdiction, clearly duplicating activities that were already taking place in many of the provincially regulated laboratories, which are already under a very constructive and thorough system of regulation and licensing.

On the regulatory burden, the committee heard from some of the university labs and others. They said that this regulatory burden would be very costly and that there were no provisions to assist with those costs. In fact, we heard that similar legislation in the United States had caused research to stop at some university research facilities. This is an unintended consequence that we do not want in Canada. We know how important primary basic research is. We know the important research these laboratories do on pathogens and toxins. Shutting down a source of research is definitely counterproductive to the goals of the bill.

Concerns were expressed by information and privacy commissioners. There were major concerns with the penalties and the criminalization of what could be an inadvertent misstep on the part of a laboratory staff person, resulting in an action that under that bill could have called for criminal penalties. There were serious concerns about the bill. Opposition members argued very vigorously that the government should take the bill back and redo it, make the necessary amendments and bring it back to the committee with the key concerns solved. At first we were being asked to accept a “trust us” message, that these things would be corrected in committee later in the process. We were not willing to do that, notwithstanding the importance of the issues and the risk that the bill was attempting to address.

After having given that context to the situation, I am pleased to say the committee members from all parties worked very constructively together. The government and the agency that was the author of the bill had the wisdom to make amendments to address some of the grave concerns raised, and those amendments were outlined in some detail by the previous speaker.

The bill that came back to the committee addressed some of those concerns, but not all of them. That is why further amendments were proposed to ensure the regulations would go to Parliament and that an advisory committee would be brought into the process of regulation making. Those were absolutely necessary amendments. I am pleased to say they are part of the bill as it goes forward. This was an occasion where the unintended consequences were serious, but they were addressed. The committee did its work. I want to congratulate all the committee members for the work on this occasion. I look forward to seeing the bill in its next iteration.

[Colin Carrie, Conservative, Parliamentary Secretary to the Minister of Health]

Madam Speaker, I am pleased to rise today at report stage of Bill C-11, An Act to promote safety and security with respect to human pathogens and toxins, to speak to the government amendments to clauses 66.1 and 66.2, which are now before us.

We heard at second reading that there is strong support in this House for strengthening safety and security with regard to human pathogens and toxins right here in Canada. We are committed to moving forward with this legislation to address the serious safety and security gaps that we have identified in order to safeguard Canadians from the threats posed by human pathogens and toxins.

Members of the Standing Committee on Health had an extensive opportunity to review all elements of Bill C-11. All told, the committee heard from five government witnesses, in some cases more than once, and from 13 other witnesses over a period of a month. In total there were seven separate sessions devoted almost entirely to review and discussion of Bill C-11. In these sessions, all voices were heard and all opinions were closely considered. The result of the committee's hard work is an amended bill that we think well reflects the underlying policy intent of the bill, as well as other key aspects of concern to some witnesses.

There were 12 amendments to the bill, of which eight were put forth by the government and four were put forth by the opposition. These amendments include a government amendment to clarify technical aspects of the bill, such as the fact that there will be no requirement to report to the minister of health when there is a simple spill in the laboratory, but only when there is a release of a human pathogen or toxin from the facility itself.

As well, two opposition amendments were put forward to require the establishment of scientific advisory committees to advise the minister of health regarding the schedules to the bill. These amendments, which the government supports, go a long way in ensuring there is an evidence base for decision-making on how to treat dangerous, and less dangerous, pathogens.

Two other government amendments responded to input that the committee received from the office of the Privacy Commissioner, which we believe resulted in better privacy protection in this bill.

The bill was also amended to clearly articulate that there will be no security screening of persons accessing risk group 2 human pathogens and to signal that the regulations should be drafted taking into account the varying degrees of risk between risk groups of human pathogens and between toxins. As well, the penalty clauses in Bill C-11 were amended to lower the penalties related to contraventions of the act and regulations related to risk group 2 human pathogens.

These amendments were made to respond to what we heard from numerous witnesses at committee who strongly emphasized that risk group 2 human pathogens, although clearly capable of causing serious disease and death, posed lesser risks. Therefore they warranted less stringent treatment both in the bill and in the regulations.

We heard what these witnesses had to say and the government was comfortable proposing these numerous amendments which were all agreed to at committee.

In addition to the successful amendments put forward at committee, two amendments are related to a requirement for the tabling of regulations made under Bill C-11 before both Houses of Parliament. These amendments were put forward by the opposition and became the new clauses 66.1 and 66.2. They were agreed to by the committee, including the government members, subject to one qualification.

The government responded to these proposed amendments by requesting that the words “and the Senate” be added where the words “House of Commons” appeared in the amendments, to ensure that the regulations would also be tabled there.

After some discussion, the committee agreed to the suggestion, which was considered a friendly amendment, with agreement that the changed amendments would be worded in a way similar to what is now found in the Assisted Human Reproduction Act.

Unfortunately, upon review of the bill as reported from the Standing Committee on Health, it became obvious that this last specific requirement relating to the tabling of regulations in both Houses of Parliament was not included in the amended bill, as was requested by the committee.

Many of the needed references to the Senate, and particularly the fact that the regulations must be referred to a committee of that House, were simply left out. The government has put forward amendments at report stage to address this omission.

More specifically, the government has proposed an amendment to clause 66.1 to require that the regulations be tabled before each House of Parliament and that a proposed regulation that is laid before Parliament shall be referred to the appropriate committee of each House, as determined by the rules.

The new clause 66.2 allows for some specific exemptions from the requirement to table regulations in both houses of Parliament. The proposed government amendment now before us specifies that should the Minister of Health make a regulation without first laying it before either house of Parliament, she must lay before each house a statement of reasons for doing so.

These proposed government amendments to clauses 66.1 and 66.2 are completely in line with the wordings of section 66 and 67 of the Assisted Human Reproduction Act as requested and agreed to by the Standing Committee on Health.

The bill, with these new amendments, reflects the hard work and co-operative approach that was taken at committee, reflecting the need to work together to safeguard the health and safety of Canadians. I would like to take this opportunity to thank the members of the committee for a job well done.

I request that the House agree to these amendments, which simply reflect what the committee had previously agreed was the right way to proceed, in the same spirit of co-operation and concern for the health and safety of Canadians that was apparent in all of the discussions around Bill C-11 that occurred in committee.

As I noted, we believe that the amended Bill C-11, which was reported to the House from committee, is a stronger piece of legislation that well reflects the policy intent of the legislation and concerns expressed by some witnesses at committee. These government amendments to clauses 66.1 and 66.2 will essentially complete the good work of the committee by ensuring that the amended Bill C-11 reflects what was actually agreed to by committee in consideration of the input of many witnesses over a period a month.

Speaker's Ruling

[The Acting Speaker, NDP, Denise Savoie]

There are two motions in amendment standing on the notice paper for the report stage of Bill C-11. Motions Nos. 1 and 2 will be grouped for debate and voted upon according to the voting pattern at the table.

The House proceeded to the consideration of Bill C-11, An Act to promote safety and security with respect to human pathogens and toxins, as reported (with amendment) from the committee.

Business of the House

[Jay Hill, Conservative, Leader of the Government in the House of Commons]

Mr. Speaker, today, Bill S-3, the energy efficiency bill, was read a second time and referred to the Standing Committee on Natural Resources.

Just before question period, we were debating Bill C-13, the Canada Grain Act, but it appears the coalition of the Liberals, the NDP and the Bloc has been revived and it is supporting a motion that, if adopted, will defeat that bill. It is proposing to kill the bill before it even gets to committee. It is unfortunate that the coalition's first act is to abdicate its role as legislators by denying close scrutiny and study of a bill at a committee.

After my statement, the government will be calling Bill C-5, Indian oil and gas, followed by Bill C-18, the bill respecting RCMP pensions, which is at second reading.

Tomorrow, we will continue with the business that I just laid out for the remainder of today.

When the House returns on April 20, after two weeks of constituency work, we will continue with any unfinished business from this week, with the addition of Bill C-25, the truth in sentencing bill, Bill C-24, the Canada-Peru free trade agreement, Bill C-11, human pathogens and toxins and Bill C-6, consumer products safety. We can see we have a lot of work to do yet. All of these bills are at second reading, with the exception of Bill C-11, which will be at report stage.

During the first week the House returns from the constituency weeks, we expect that Bill C-3, the Arctic waters bill will be reported back from committee. We also anticipate that the Senate will send a message respecting Bill S-2, the customs act. If and when that happens, I will be adding those two bills to the list of business for that week.

Thursday, April 23, shall be an allotted day.

Health

[Joy Smith, Conservative, Kildonan—St. Paul, MB]

Mr. Speaker, I have the honour to present, in both official languages, the first report of the Standing Committee on Health in relation to Bill C-11, An Act to promote safety and security with respect to human pathogens and toxins.

Your committee examined the bill and has decided to report it with amendments and has ordered its reprint. I would like to thank all members of the committee for their hard work and cooperation.

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

Parliamentarians are entitled to receive notice of an interim order much sooner than within 15 days. The problem is that in the case of the Quarantine Act, 15 days may be too long a period of time. The time frame should be shortened in that act as well as in Bill C-11.

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

Thank you, Madam Chair.

I just want to come back to the comment made by certain members—including yourself, Madam Chair—to the effect that we could be responsible for some unfortunate incidents that might occur. It is clear to all of the witnesses and to colleagues seated at this table that the safety of the public is our main focus.

Draft legislation, Bill C-54, was tabled during the previous Parliament. Since then, there has been time to do some impact assessments. These would have helped us to determine either that the bill would be damaging to the research, university and scientific community or conversely, that there was no cause for concern, that everything would be fine and that there would be no brain drain as we saw happen in the United States because here, we were going to take a different approach.

However, it is clear that such studies would have proved invaluable to avoid our heading off in many different directions. The concerns that were expressed could have been addressed. When we had our first briefing with the Agency when Bill C-11 was tabled, we were told that consultations had taken place, that everyone was satisfied and that there was no cause for concern. However, as we started to hear from witnesses, concerns were voiced by many different parties.

Madam Chair, the crux of the problem is the fact the government has chosen to focus more on criminal provisions and on putting in place parameters and regulations, insisting that people will be reassured by this. However, the reality is that hundreds of research facilities, universities and hospitals that do research are today asking themselves what will happen to them once Bill C-11 is adopted.

As parliamentarians and as a responsible committee, we should have taken their concerns into account during our study of the bill. It is unfortunate that today, as we proceed with the clause-by-clause study, we are not in a position to reassure the vast majority of the witnesses who came here to testify. That is what saddens me the most today.

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

Madam Chair, you are going to tell me that it's always the people who are not there that get the blame, but before I talk about the amendment to clause 3, I would just like to say that after reading last week's testimony, I still have a number of questions about the scope of the bill. I'm quite surprised to see us move today to the clause-by-clause study phase and to learn that the government has quite simply decided not to propose any substantive amendments to the bill that would alleviate some of the concerns that were expressed. I'm surprised that the government did not take a step back and review the bill in light of the comments we received and the comments we are likely to hear in the coming days and weeks.

That said, Madam Chair, a vote was taken and I accept that it is time for the committee to move to the clause-by-clause study phase. That is what we will do. Of course, I will be proposing a number of amendments, as several of my colleagues will be doing as well, in an effort to address some of the witnesses' concerns. The proposed amendments to clause 3—in fact, the three amendments— are similar in that they call for the exclusion of the micro-organisms listed in schedule 2 from the definition of “human pathogen“, given that several witnesses have stated that risk group 2 pathogens should not be subject to the same rules as risk group 3 or risk group 4 pathogens. You will tell me that the government has attempted to put in place a number of safeguards further on in the bill to limit the scope of the bill in terms of criminal implications.

However, strictly from the standpoint of risk, because I do think BillC-11 has far more to do with evaluating risk and the implications and consequences of imposing this legislative framework and especially the upcoming regulatory framework the scope of which is still unknown, it is important the any reference to risk group 2 pathogens be removed from the definition, given that— and we heard this from the witnesses—there are costs associated with this reference. There are implications for education, the evolution of knowledge, the exchange of scientific information and the development of research. I did not hear any evidence convincing me that all micro-organisms that are or that could be present or could be present should be included in the definition of “human pathogen“. Further on in the bill, we see that the minister has certain regulatory authority to add certain types of micro-organisms to the list of substances in the schedules.

In my opinion, Madam Chair. . .

[Nicolas Dufour, Bloc, Repentigny, QC]

Thank you.

From the outset, Dr. Butler-Jones told us that you had looked at legislation in other countries to get an idea of what aspects could be included in Bill C-11. However, the scientists have shown us that the list is much shorter in the United States and that we should perhaps move in that direction rather than the much more rigid structure of Bill C-11.

Just now, the scientists told us that, because of the proposed fines, they feel that they are under attack, even before the bill is passed. They are already being treated like criminals. As you know, people have to be found guilty before they can be fined. We must not forget that legislation exists to be used.

I am surprised by one thing. Fines can be imposed, but on whom? Is it the universities, the hospitals, the professors? We all know that this is provincial jurisdiction.

On the one hand, you tell me that the legislation will not be challenged, that it will move forward and that the provinces see no problem with it. On the other hand, who gets fined? If we start fining hospitals and universities, we are going right into provincial jurisdiction, it seems to me.

[Dr. Albert Descoteaux, Professor, Institut Armand-Frappier, Institut national de la recherche scientifique]

Thank you again for giving me the opportunity to express some fears or concerns about Bill C-11. I would like to take the opportunity to raise a matter that went unnoticed last time: bacterial toxins.

The CDC in the United States consider two or three toxins to be really dangerous. Most of the toxins on the list are very important research tools. We use them to study how cells work in cancer, in neurology and in immunology. Examples are the cholera toxin, the Clostridium botulinum toxin and the pertussis toxin. I am afraid that, if access to these toxins becomes too complicated, it could be very detrimental to research in cellular biology.

I also have some concerns about HIV. In the bill, HIV is classed at level 3. But it is a fact that several research groups and research networks in Canada have established sample banks, with samples taken from thousands of patients infected with HIV. These banks are invaluable for HIV research. One example is the Réseau SIDA et Maladies infectieuses, run by the Fonds de la recherche en santé du Québec. Members of that network have access to various banks of samples: from patients with primary infection, from slow progressors, and from patients infected with HIV and the hepatitis C virus.

Since HIV is now in containment group 3, I seriously wonder about the impact that Bill C-11 could have on the access to, and use of, these thousands of samples by qualified researchers. We can only imagine the bureaucracy and the permits needed for laboratories to exchange strains. And it is not just networks. Hundreds of professors and students need to handle and use these lines. We run the risk of setting up a huge logistical challenge, not to mention the impact on AIDS research.

I have to point out that these sample banks were established with grants from federal and provincial organizations. Bill C-11 would destroy all the financial commitments from government in the fight against AIDS. Paradoxically, that remains a federal government priority. I would really like that considered when you decide your position on Bill C-11.

There has also been talk of micro-organisms potentially being used for malicious purposes like bioterrorism. I have given Mr. Etoka a list from the Centers for Disease Control's website in Atlanta. The list is in English only and has not been circulated to everyone, but you can easily get it. It is a list of agents that can be used in bioterrorism.

The first thing we see is that the list of micro-organisms that are considered very dangerous is very short. There are six: anthrax, botulism, plague, smallpox, tularemia and the hemorrhagic fevers.

The second thing we notice is that these micro-organisms all belong to confinement groups 3 and 4, except smallpox, which is in group 5.

The third thing is this. In the list of micro-organisms that the CDC consider less dangerous because of their moderate morbidity and low mortality but that could still be potentially used for bioterrorism, some are in confinement group 2, like salmonella, some strains of E. coli, like 0157:H7, vibrio cholerae and cryptosporidium. In general, these are the micro-organisms most often responsible for food poisoning or contaminated water. Poisonings and contaminations of that kind are often due to poor hygiene practices or negligence on the part of the people in charge of water quality.

After I appeared here two weeks ago, I have had discussions with my colleagues and I have thought about the matter some more.

I would like to end with a recommendation. If the goal of lawmakers is to promote public health and safety in the area of micro-organisms and to protect Canadians from potential bioterrorist attacks, Bill C-11is not the solution. I feel that the bill could well create havoc by establishing a repressive system that lumps all micro-organisms together, whereas the vast majority of them pose no problem at all for people's health and safety. My recommendation is that lawmakers and the Public Health Agency of Canada concentrate on the few micro-organisms that potentially can be used maliciously and put in place appropriate measures for them.

Thank you for your attention. I will be pleased to answer your questions.

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

Thank you.

Earlier, Mr. Ghalami testified that the application of Bill C-11 could result in a brain drain. Can you give us any solid numbers as to the potential impact of the bill, given that witnesses have told us about lab closures in the United States? Mr. Ghalami even said that Canada had benefited from an influx of eminent researchers. Have you truly weighed the impact of the bill, to avoid having to contend with a similar situation here?

[Dr. Wayne Conlan]

I do, yes. This was for Bill C-54, not for Bill C-11, but I was certainly apprised very fully of its content and was given the opportunity to comment on it by the Public Health Agency of Canada.

[Dr. Wayne Conlan]

As I receive a lot of my funding from the U.S., I have to abide by the equivalent of Bill C-11 with the select agent rule. That's a little different because pathogens are considered select agents not based on their risk group. So you can be a risk group two pathogen and still be a select agent, and then you are governed by the select agent rule, whereas in Canada you would be a risk group two pathogen, and some risk group two pathogens would certainly be treated even under Bill C-11 with less concern than they would be if they were being handled in the U.S.

[Dr. Wayne Conlan]

Is it going to have some impact on research? Sure, but if you work with animals, the red tape surrounding the use of laboratory animals is far more onerous than the red tape proposed for level two pathogens by Bill C-11. The red tape surrounding the use of radioisotopes in laboratories is more onerous than the red tape for level two pathogens proposed by Bill C-11. We have to have inventories of all the chemicals in the laboratory; why shouldn't we have an inventory of all the pathogens in the laboratory too?

The Public Health Agency of Canada, over the years, has produced MSDS sheets for just about all of these pathogens, with really good, detailed instructions about how to handle them. So there's really no excuse not to go this one extra step and just have a list of who's got what. I would hope that the Government of Canada would like to know who's got what—and where they've got it, as well. That's the whole essence of Bill C-11, knowing where pathogens are kept.