This bill was last introduced in the 40th Parliament, 2nd Session, which ended in December 2009.
Leona Aglukkaq Conservative
This bill has received Royal Assent and is now law.
This is from the published bill.
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.
All sorts of information on this bill is available at LEGISinfo, an excellent resource from the Library of Parliament. You can also read the full text of the bill.
Chuck Strahl Conservative Chilliwack—Fraser Canyon, BC
moved that Bill C-11, An Act to promote safety and security with respect to human pathogens and toxins, be read the third time and passed.
Colin Carrie ConservativeParliamentary Secretary to the Minister of Health
Madam Speaker, I want to start off by taking the opportunity to thank the opposition parties, especially the critics from the NDP, the Bloc and the Liberal Party, for all their hard work and co-operation in working on this very important piece of legislation.
I am pleased to be here today to update members on the progress of Bill C-11, An Act to promote safety and security with respect to human pathogens and toxins.
As we have heard at second reading, there is strong support for strengthening safety and security with regard to human pathogens and toxins in Canada.
We had an opportunity at the Standing Committee on Health to discuss the key elements of the bill, which would provide the new authorities required to safeguard Canadians from the risks that dangerous human pathogens and toxins pose.
The Standing Committee on Health heard from a wide variety of witnesses about the importance of Bill C-11. Following witness testimony, as well as appearances by government officials from the Public Health Agency of Canada, amendments were made to Bill C-11 that have strengthen the bill and addressed many of the concerns raised by witnesses.
I would like to give members a quick overview of the bill.
The intention of the bill is to try to balance biosafety and biosecurity requirements with the need to advance science and research. The intent of the bill is not to restrict research and development, but rather to introduce a risk-based approach to the management of human pathogens so that they are handled safely and accounted for across Canada.
Because of the risk posed by dangerous human pathogens and toxins, Bill C-11 relies primarily on the criminal law jurisdiction of Parliament. In this regard, Bill C-11 includes a range of prohibitions, penalties and security screening requirements designed to protect the health and safety of Canadians.
The program and regulatory framework to be developed under Bill C-11 will include requirements for licensing, inventories, biological safety officers, information gathering and transfers of human pathogens and toxins, among other matters. The legislation has been drafted with care to ensure that the bill fully respects the rights and freedoms of Canadians entrenched in the Charter of Rights and Freedoms and privacy rights protected via the Privacy Act.
There were certain amendments to the bill. In studying Bill C-11, several issues were raised from various witnesses concerned about the impact of the bill on their work. These issues included concerns about the oversight of risk group 2 laboratories, concerns about how the suite of regulations for Bill C-11 would be developed, concerns about the reporting requirements, as well as concerns about the schedules under the bill and how they would be amended over time.
We listened to these concerns, and I believe we have worked together at the health committee to develop a piece of legislation that addresses these concerns and more precisely reflects the original policy intent of Bill C-11.
Now I would like to speak about risk group 2.
With regard to the concerns that the committee heard about the oversight of risk group 2 human pathogens, several amendments were made to clarify that these relatively less harmful agents would be treated less stringently than the more dangerous risk groups 3 and 4 human pathogens, in the bill and in the program and regulatory framework. Four specific amendments were made for this purpose.
The first amendment clarifies in the preamble that human pathogens and toxins pose varying levels of risk to the health and safety of the public. This change reflects what was heard in committee, that not all human pathogens and toxins are the same from the perspective of risk, that some pose a greater threat than others.
The second amendment dealing with risk group 2 agents clarifies clause 33 explicitly so that security clearances will only be required for persons who have access to prescribed risk groups 3 or 4 agents or toxins as prescribed in regulations. It was never the program policy intent to security screen individuals who only have access to risk group 2 human pathogens, and this amendment clarifies this intention.
The third amendment regarding risk group 2 agents creates lesser general penalties for offences under the act or regulations related to risk group 2 human pathogens. This includes no provision for a prison sentence for a first offence involving only risk group 2 agents. This change to clause 53 reflects concerns voiced that persons carrying on activities with risk group 2 human pathogens should be treated more leniently than those carrying on activities with risk groups 3 or 4 human pathogens.
Finally, the fourth amendment, in clause 66, makes explicit that the regulatory regime will treat risk group 2 human pathogens in a way that is consistent with the fact that they are less dangerous than human pathogens in risk groups 3 and 4. Taken together, these changes signal that the level of risk associated with risk group 2 human pathogens is lower than risk groups 3 or 4, and they will therefore be treated less stringently in the overall legislative and regulatory framework.
Regarding reporting requirements, another important amendment that was made at the health committee clarifies that subclause 12(1) of the bill only applies to releases of human pathogens or toxins from a facility. This stems from concerns that were heard from stakeholders that minor spills contained within a licensed facility would have to be reported. This amendment recognizes that releases from the facility itself pose greater risks to public health. Once again, we believe this will help to improve the clarity of the bill, specifically with regard to what will be required of licensees.
Another important amendment requires the formation of scientific advisory committees under clauses 9 and 10 to advise the minister regarding changes to the lists of human pathogens and toxins found in schedules 1 through 5. As part of the consultations on the program and regulatory framework, the Public Health Agency of Canada will consult with stakeholders concerning the makeup of these committees, which be will formed under the authority in section 14 of the Public Health Agency of Canada Act.
Concerning privacy amendments, during hearings on Bill C-11, the health committee received a letter from the Privacy Commissioner noting, amongst other things, the need for a more objective test of what constitutes relevant information collected by the minister under clause 38, as well as the need for situations in which recipients of information disclosed by the minister pursuant to subclause 39(2) may be compelled by law to disclose it further. These two amendments were made based on suggestions from the Privacy Commissioner.
The last of these important amendments requires the tabling of the regulations in both houses of Parliament. This amendment reflects what we heard from witnesses about the need for greater accountability and transparency in the making of regulations. In reviewing the wording of this particular amendment, the government noted some inconsistencies between the intention of what was stated in the health committee and what was written into the revised Bill C-11.
Specifically, it was agreed that the amendments would require tabling of the regulations in both houses of Parliament in order to provide an opportunity for review by a committee in each house. The wording of the bill after committee stage only required the referral of the proposed regulations to a committee in the House of Commons. There was no similar requirement regarding the referral of the regulations to an appropriate committee in the other place.
The government therefore clarified that the regulations would need to be tabled in both houses of Parliament and referred to a committee of each house. We believe this was the original intention of committee members in agreeing to this amendment, and we tabled an amendment at report stage from committee to clarify this intention.
There is a need to move forward. We believe this new legislation is needed now. It is required to safeguard the health and well-being of all Canadians, including those persons working in laboratories. It is also required to demonstrate to the Canadian public and to our international partners that the Government of Canada is taking the issue of security related to human pathogens and toxins very seriously. The proposed legislation represents a made-in-Canada approach that addresses both safety and security.
Clearly, the urgency in moving ahead with expanded federal oversight over human pathogens and toxins has been widely recognized. I believe the study of Bill C-11 in the health committee has resulted in a clear piece of legislation, and I look forward to moving it on to the Senate.
Jim Maloway NDP Elmwood—Transcona, MB
Madam Speaker, I know the NDP critic takes this issue very seriously and I know she has worked very hard on the bill.
I wonder if the member could tell the House which of her amendments were accepted in the bill.
Colin Carrie Conservative Oshawa, ON
Madam Speaker, indeed, the member is correct. The NDP critic worked very hard and co-operated with the government and the entire committee to move this very important piece of legislation forward.
As I said in my opening statement, I want to thank all the critics and members of the committee, the NDP, Bloc and Liberals. By working together, we came up with an improved piece of legislation.
The amendments that the NDP member put forward were included. We listened to her suggestions because we felt it made a better piece of legislation and I want to publicly thank her for her input and good work.
Paul Szabo Liberal Mississauga South, ON
Madam Speaker, I am glad to see the committee has done good work to get some clarifying changes.
I want to ask the member for a little extra information with regard to subclause 12(1), the addition of the words “from the facility” following the words “reason to believe that a human pathogen or toxin has been released inadvertently”.
The point is that “facility” is not a defined term in the bill. I do not know whether that has any import, but it would seem to me that if it is not a defined term, facility could in some cases turn out to be something other than what would normally be the case under a licence arrangement. I would ask the member for clarification as to whether just adding the words “from the facility” is substantive enough or whether there should be a definition added for what constitutes an authorized facility?
Colin Carrie Conservative Oshawa, ON
Madam Speaker, this very issue was brought up in committee. There was concern with some of the researchers who were working with these pathogens and toxins. As the member would know, even though researchers working in laboratories take the utmost precautions, spills can occasionally happen.
The intent of this legislation is not to force laboratories and workers to report what we would call usual spills in conducting their research but if there are inadvertent releases from the laboratory into the public domain. The idea of this legislation is to improve biosafety and biosecurity in Canada. There is still a very strong concern that these pathogens and toxins will not be released to the general public and will not cause a concern to our health and safety in Canada.
This was something put forward by the government and that all opposition parties were in agreement with. We were happy to clarify that wording because that definitely is the intent.
Joy Smith Conservative Kildonan—St. Paul, MB
Madam Speaker, I too want to commend the parliamentary secretary for all the work he did on this bill, as well as the committee. It was very good. One thing that came up in committee was the risk 2 category that was of grave concern to the entire committee. I believe there were marked changes in the approach to the risk 2 category.
Would the parliamentary secretary please expand a bit on the risk 2 factor because the contribution that the committee made to that one aspect was very important?
Colin Carrie Conservative Oshawa, ON
Madam Speaker, I would like to thank the hon. member for her wise oversight as chair of the health committee. It was through her leadership that we were able to move forward with this legislation. She was very good at working collaboratively and developing consensus with the different witnesses as well as the members of committee. I thank her for that.
She brings up a very important point. It was acknowledged that the intent of the legislation was to treat risk group 2 human pathogens differently than groups 3 and 4, so it was very important to clarify exactly what was meant. There were three amendments included that recognized that facilities dealing only with risk group 2 human pathogens should be treated less stringently under the bill, the program and regulatory framework, as they are less risky than human pathogens in risk groups 3 or 4 or toxins.
There was also an amendment included which specified that there will be no requirement for security screening of persons with access to only risk group 2 human pathogens, as well as an amendment to lower the possible penalties for contraventions of the act or regulations involving only risk group 2 human pathogens.
The government also proposed two further amendments to respond to the concerns expressed by the Privacy Commissioner and moved those forward as well. I hope that answers the hon. member's question.
Luc Malo Bloc Verchères—Les Patriotes, QC
Madam Speaker, I have a question for the minister's parliamentary secretary.
He said that in our study of the bill in committee, we heard from various stakeholders directly affected by Bill C-11. He also seemed to be saying that the amendments he read met the demands and expectations of those very stakeholders, that is, the researchers who work daily with the micro-organisms targeted by this bill, specifically group 2 micro-organisms.
However, although the various researchers were aware of the amendments, how can he explain the fact that, on the last day of consultations with them, before clause by clause study began, the researchers still had reasonable, legitimate, well-founded fears lingering in their minds? How can he explain the fact that the government nonetheless decided to go ahead with the clause by clause study knowing that those particular stakeholders were dissatisfied with the final product?
Colin Carrie Conservative Oshawa, ON
Madam Speaker, the member is quite correct. There are stakeholders who feel that this legislation, like any piece of legislation, is not perfect. However, I think the member realizes that in any type of legislation there has to be a balanced approach. We have to decide and debate what we want in the legislation and whether we want to move forward with the regulations.
I was impressed with Health Canada when it said that it would consult with us and give strong consideration to this piece of legislation through the implementation phase. We also brought forward an amendment for an advisory committee.
The member may be totally correct in saying that not all stakeholders believe that this is perfect legislation, but it did pass committee and we did have a good debate.
Overall, we have come up with a good piece of legislation, a balanced piece of legislation. The Canadian public deserves legislation that would protect their biosafety and biosecurity. This government and all opposition parties are in line with that intent, that is for sure.
James Lunney Conservative Nanaimo—Alberni, BC
Madam Speaker, I want to compliment the parliamentary secretary on his management of the committee and for the way he steered the bill through committee. He had a lot of co-operation from opposition parties along with the chair who spoke just a moment ago.
Canada really has a stellar international reputation in managing pathogens as evidenced by the H1N1 worldwide crisis. Canada is receiving pathogenic material from Mexico and helping it to analyze the bug that has been causing problems down there.
I wonder if the parliamentary secretary would comment on whether the provisions in Bill C-11 would help to ensure that we maintain our leadership role and would help to secure Canada's position as a leader in managing human pathogens.
Colin Carrie Conservative Oshawa, ON
Madam Speaker, there are about 3,500 laboratories that import these agents into Canada and they are covered under the existing importation regulations. However, there are approximately 4,000 other laboratories in Canada that work with human pathogens and toxins, but they do not import them and they are not subject to the same federal regulation and oversight. These laboratories may be applying national laboratory safety guidelines on a voluntary basis, but the precise extent of this application is unknown.
That is why we have this legislation to ensure that Canada's reputation remains stellar worldwide.
Kirsty Duncan Liberal Etobicoke North, ON
Madam Speaker, today I rise to speak to Bill C-11, the human pathogens and toxins act, adopted by the Standing Committee on Health on March 31 and presented to the House on April 2, 2009. The bill is important and significant because infectious disease remains among the leading causes of death worldwide and the greatest killer of children and young adults.
Today, new infectious diseases such as HIV-AIDS, SARS and now swine influenza A(H1N1) are emerging. Old infectious diseases such as malaria, plague and tuberculosis are re-emerging, and intractable infectious diseases remain an ever-present threat. Research to combat infectious diseases has resulted in over 5,000 laboratory-associated infections and almost 200 deaths over the last 70 years. Most recently, in 2008, the Bush administration acknowledged that the Plum Island Animal Disease Center, the only U.S. facility allowed to research highly contagious foot-and-mouth disease, experienced several accidents with the virus.
Fortunately, Canada has not experienced a large intentional or unintentional release of a dangerous agent. However, we have had some close calls. In April 2005 a facility in Canada imported a live virus sample under a risk group 2 permit. However, laboratory analysis showed that the material was contaminated with a risk group 3 pathogen: namely, influenza A(H2N2). Once the contamination was confirmed, the Public Health Agency of Canada's importation office, in consultation with the World Health Organization, the U.S. Centers for Disease Control and the provincial health ministers contacted the supplier of the material and all facilities in Canada that had been issued a permit for the same panel and advised them of corrective action.
It was only because the material was imported that the federal government was able to track who had the affected materials. Should this situation happen today in Canada, with a domestically produced product, there would be no authority or ability to track materials and advise affected parties of corrective action. This could result in a biosafety and biosecurity risk as Canadians would likely have no immunity to the influenza A(H2N2) virus, possibly creating the conditions for the next influenza pandemic. This is why the legislation is so important.
Currently, PHAC has knowledge of laboratory-acquired infections, but has no national reporting mechanism to capture them. Our laboratories must have strict facility safeguards, microbiological practices and safety equipment to protect laboratory workers, the environment and the public from exposure to infectious micro-organisms and toxins that are stored in the laboratories. We must ensure the safety of all Canadians.
Therefore, we must be diligent in creating a legislative base that balances biosafety without impeding scientific advancement. We must also provide assurances to the Canadian public and our international partners that Canada takes biosafety and biosecurity seriously.
Bill C-11 will only succeed in making Canadians more secure if the scientists it regulates are consulted thoroughly and if the bill is implemented in close partnership with them. Canadian economic and social prosperity depend on scientific study. We must be wary of a regulatory regime that would interrupt discovery, as happened in the United States following publication of similar legislation. Many laboratories simply stopped working with listed pathogens rather than face the costs and hassles of complying with the legislation.
I believe Bill C-11 strikes the necessary balance between mitigation of risk and scientific freedom, which must then be maintained in the regulations. This balance will require, in the words of one witness, “constant attention and rebalancing that can be done only through ongoing dialogue with the scientific community”.
Witnesses from PHAC assured the committee that consultations will help determine what the regulations regime will look like. Witnesses were optimistic that they could move forward together with partners and that they would continue to take action to address their concerns.
The committee recommended the creation of an external advisory group, perhaps consisting of representatives from private industry, provincial public health agencies, universities and others to ensure that the regulations and the subsequent implementation of the bill proceed with the input and the support of the scientists.
The proposed external advisory group could also be instrumental in categorizing pathogens, as there was discussion regarding, for example, whether or not certain risk group 2 pathogens should be removed from the schedule. Removing risk group 2 from the legislative framework would take away the ability to know who has those pathogens, which are the majority of pathogens in Canada, the ability to assess whether they are handled in an appropriate manner and the ability to measure laboratory-acquired infections and their impacts.
There was general agreement that risk group 2 should be handled in a safe manner, which is not necessarily happening now, but less stringently than risk group 3.
Witnesses from PHAC also addressed stakeholder concerns regarding financial expenditures. It was pointed out that these costs must be balanced against the cost of taking no action, mainly loss of credibility, dollars and human life, which are significant in this case.
Other stakeholder concerns included duplicate laboratory licensing regimes, security checks, licences and privacy issues. The potential for duplicate regulatory licensing and inspection regimes is significant, as is the possible impacts on workload and scheduling which could drastically affect the operation of clinical, public health and research laboratories.
Witnesses from PHAC agreed that opportunities for harmonizing licensing with existing regimes must be considered. Witnesses from PHAC also agreed to clarify the requirements for security clearances for different categories of workers.
Security checks were thought to be burdensome by stakeholders due to significant impacts on students and training, as well as the lab's ability to hire additional staff during an outbreak. Stakeholders would like PHAC to clarify who the inspectors will be, how they will be trained and how they will carry out their tasks.
Partners would also like PHAC to address the important issues regarding licensing. For example, to whom a licence should be awarded, the institution, the group or the individual? What conditions will be required for awarding licences? Will there be an appeals process? Will custodial staff have access to labs? Will they require security clearances?
The last concern I will address is that of privacy, as clause 38 of the bill identifies extremely broad powers for the minister to order an applicant to disclose personal information. It is the committee's understanding that conversations have taken place with the Privacy Commissioner to satisfy stakeholder unease.
I would like to draw attention to the fact that strengthening global surveillance is not enough to eliminate or eradicate infectious disease. We need close ties among public health, trade and transportation organizations. We also need better collaboration with those monitoring the biological weapons convention, because bioterrorism remains a very real threat.
In 2004, The National Academies committee issued a report entitled, “Biotechnology Research in an Age of Terrorism”. The report identified experiments of concern, such as rendering vaccines ineffective or turning non-pathogens, which are not found anywhere in the bill's schedules, into pathogens.
We need to ensure that granting agencies and medical journals are sensitive to these matters and have processes for addressing them. The same National Academies committee recommended creating, through legislation, an independent science and technology advisory group to the intelligence community. Does such a group exist in Canada to monitor and study the next generation of threats in a comprehensive, systematic way, as is being undertaken in the United States?
Finally, the bill is only part of the web of protection needed to make Canada more secure and prepared for bioterrorism. What is being done to promote a common culture of awareness, a shared sense of responsibility to prevent misuse within the scientific community?
We need more than legislation. We need a code of ethics, role modelling and teaching with a particular focus on the biosecurity agenda in Canada.
We have had multiple wake-up calls. Complacency cannot be an option when it comes to biosafety and biosecurity, which is why this legislation is important. The committee did work hard together to make necessary modifications to the bill.
Jim Maloway NDP Elmwood—Transcona, MB
Madam Speaker, when we dealt with the bill dealing with the overhaul of the Charities Act, we were told that while the bill had been through two or three parliaments, several iterations and people had made presentations, that there were thousands of charities in Canada that were probably still unaware that the bill even existed.
We are dealing with the fact that the lab facilities would need to be licensed. I am sure we are dealing with a much smaller group than we were in the case of the charities, but does the member know how many labs we are talking about, what the procedures would be for licensing them and what sort of fees they would be paying?
Kirsty Duncan Liberal Etobicoke North, ON
Madam Speaker, we learned through our committee work that probably several thousand labs need this legislation. We currently do not know which labs, for example, hold pathogens below level four. It is important that the government knows this information because if there is a problem it needs to respond.
The legislation is important because it will protect laboratory workers and the communities.