Madam Chair and members of the committee, I am pleased to appear before the Standing Committee on Health today to discuss Bill C-11, An Act to promote safety and security with respect to human pathogens and toxins..
My colleagues have been introduced.
We have an opportunity at this committee today to discuss the key elements of this bill, which seeks to provide protections to safeguard Canadians against the health and safety risks posed by the most dangerous human pathogens and toxins. Let me first discuss the current system.
Currently, approximately 3,500 laboratories that import human pathogens or toxins are regulated under the human pathogens importation regulations. These laboratories must also comply with the laboratory biosafety guidelines, which are widely accepted as Canada's national biosafety standard.
Even though these guidelines are in place, additional legislation and regulations are required to reinforce safe laboratory practices and establish consistency. The bill seeks to do this by ensuring that all laboratories in Canada, whether federal, provincial, or private, whether or not they import pathogens, are adhering to the laboratory biosafety guidelines.
The need to enhance biosafety in Canada's labs by preventing an accidental release of these agents is one of the two primary focuses of Bill C-11. The other is the desire to safeguard Canadians from the risk of an intentional release of a dangerous agent, such as anthrax, by someone who is trying to harm Canadians.
Ensuring that persons who have access to the most dangerous human pathogens or toxins are properly security screened can ultimately reduce the risk of an intentional release of a pathogen and enhance the biosecurity standard in Canada.
The intention of the bill is to try to balance biosafety and biosecurity requirements with the need to advance science, innovation, and research. The intention of this bill is not to restrict research and development but rather to introduce a risk-based approach to the management of human pathogens so they are handled safely and accounted for across Canada.
In this vein, the program and regulatory framework around this legislation is intended to be less stringent for those individuals who are handling less dangerous pathogens and toxins and more stringent on those handling the more dangerous pathogens and toxins. For example, there is no intention of security-screening individuals working with risk group 2 human pathogens, such as salmonella, under this act.
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, inspection powers, and security-screening requirements designed to address 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 the transferring of human pathogens and toxins. The legislation has been drafted with care to ensure the bill fully respects the rights and freedoms of Canadians entrenched in the Canadian Charter of Rights and Freedoms.
The Public Health Agency of Canada has already conducted four rounds of information sessions with stakeholders.
In September 2007 a proposed legislative framework was discussed with the academic, research, and diagnostic communities as well as private industry across Canada. As well, discussions about the proposed legislation took place with the chief medical officers of health from the provinces and territories in October 2007.
Following the tabling last year of the previous version of this legislation, Bill C-54, the Public Health Agency held more information sessions with stakeholders, including the laboratory community across Canada, to gauge some reactions to the new legislation. Most sessions were open to all who wanted to attend and took place in Halifax, Quebec City, Montreal, Toronto, Saskatoon, Calgary, and Vancouver.
Stakeholders expressed agreement with the general need to enhance federal oversight of human pathogens and toxins, although they did raise some technical and operational issues regarding how the entire program would be implemented. Based on the feedback we have received from stakeholders, the Public Health Agency has developed an initial program and regulatory framework that outlines what the regulations under the bill could potentially look like.
With regards to the financial impacts of Bill C-11 on laboratories across Canada, although we cannot anticipate for certain what the costs will be until the full suite of regulations have been developed, we anticipate that there should be little impact on laboratories that are already in compliance with the laboratory biosafety guidelines.
In addition, avoiding unnecessary financial burdens on laboratories is a priority. For this reason, to help laboratories adjust to the new requirements, it's envisaged that the act will be implemented in three phases to allow time for stakeholders to adjust to new requirements without unduly interfering with research activities, with a view to minimizing any potential costs.
A concern was raised at second reading about potential privatization. The policy intent of this bill is not to privatize public laboratories. The Public Health Agency of Canada will conduct in-depth and meaningful consultations with stakeholders across the country to discuss the program and regulatory framework. These consultations will include the matters that stakeholders identified to us, such as inventories, licensing, and security screening. This will help balance the needs for biosafety and security on the one hand and the interests of ongoing and innovative science and research on the other.
Madam Chair, Bill C-11 is required to safeguard the health and well-being of Canadians. The bill will finally enable Canada to eliminate the biosafety and biosecurity gap that has been filled by most of its G8 partners. As we learned during consultations and information sessions, most stakeholders recognize the need to move ahead with expanded federal oversight of human pathogens and toxins. We look forward to the committee's inquiries regarding this important piece of legislation.
Thank you very much.