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Bill C-11: Human Pathogens and Toxins Act

Honourable Senators, I stand before you today determined and pleased to support the passage of Bill C-11 and the welcome and critical legislation it proposes.


Originally drafted in late 2007 and early 2008, Bill C-11 was tabled in February of this year—one of the first pieces of legislation in the second session of the 40th parliament. It was reviewed by the House of Commons Standing Committee on Health in March, and is progressing well through Parliament.


Now referred to our own Senate Committee on Social Affairs, Science and Technology, the Bill is before us for our sober consideration.


The purpose of the Act is to ensure that the Government of Canada can track who is working with which human pathogens and toxins, and where those substances are.  Further, it requires (at last) the security screening of people dealing with the most dangerous of these agents. In my opinion, the legislation is urgently required to close serious gaps in our biosafety and bio-security framework.


In the drafting of this legislation, the Minister of Health consulted across disciplines, across the country and even across international borders to ensure the focus and the fairness of its provisions. Among the many outstanding contributors to the process, Dr. Carolyn Bennet, Member of Parliament for St. Paul’s and Judy Wasylycia-Leis, Member of Parliament for Winnipeg North, worked diligently and tirelessly to ensure that the Act meets the needs head on.


The aim of the Bill is not to impose any unnecessary burden on either laboratories or governments. Its aim is to protect the public.


The twin concern of our government in tabling this legislation is safety and security. To ensure both, the government will move ahead with new regulations to protect Canadians against the many risks posed by human pathogens and toxins. And without doubt, the legislative and regulatory measures proposed in the Act are reasonable and necessary for the welfare of our society.


A human pathogen is a bacteria, virus or other micro-organism that makes humans ill, or kills them. A toxin is a poison of plant or animal origin that has the same effect by causing an extreme immune reaction.


Human pathogens include names we know all too well: Salmonella, Listeria, SARS and Anthrax among them.  They also include the H1N1 influenza virus that is so much on our minds today.


Toxins include those related to cholera, diphtheria and tetanus.  What all of these agents have in common is that they are dangerous to the health of humans.


Yet pathogens and toxins are used routinely in medical research into the nature of human disease, in the pharmaceutical industry for development of new drugs, in the academic community for the training of doctors, nurses and biologists and, of course, at hospitals, clinics and laboratories for the diagnosis of disease.


Human pathogens are grouped according to their risk factors related to human health.


The most dangerous pathogen of all is smallpox, found in Risk Group 5. Thanks to decades of resolute effort, smallpox is unknown in Canada at present.


The next most dangerous human pathogens—Risk Group 4—spread quickly with devastating effect. Once ingested, these pathogens offer the victim very limited options. Ebola is an example.


In Risk Group 3 are those pathogens with high risk to individuals, a low risk of contagion, and some treatment options for sufferers. They include yellow fever, tuberculosis and Creutzfeldt-Jakob disease.


Risk Group 2—with names such as Listeriosis, legionnaire’s disease, and influenza—have moderate risk to individuals, low risk to the community and, usually, a variety of treatment options. While many strains of influenza fall into this group, the severity of H1N1 puts it in Risk Group 3. That’s so extra precautions may be taken when dealing with H1N1 in the laboratory, at least until the level of risk associated with it is better understood.


This Act has a simple objective—that every person carrying on activities with these dangerous agents can and must do so in a safe manner.


That objective has a precedent. Almost 20 years ago, laboratory safety guidelines were published to guide the handling of biological substances across the country.


Unfortunately, only half of the laboratories in Canada are required to follow this national safety standard. Bill C-11 legislation closes that gap by making reasonable demands on the conduct of those using toxins and pathogens in their work—right across the country.


At last there will be uniform, mandatory standards for the production, storage, handling, disposal and transfer of pathogens and toxins in Canada. As a foundation, all persons in Canada dealing with human pathogens and toxins will have to follow the laboratory safety guidelines.


This provision is the most logical way to detail the required practices. Laboratories that already follow the guidelines will see little or no impact on their operations. Those who have not will be given both the time and the guidance to do so.


Honourable Senators, I note that when the House committee worked with the Bill, 12 prudent amendments were suggested to strengthen and clarify many of the important provisions. Those amendments appear in the legislation  now before us, and attest to the collegial environment in which the Bill was created.


For example, clauses 9 and 10 now require the Minister to establish and consult a scientific advisory committee whenever any changes to schedules 1 through 5 are proposed. That means that moving a pathogen on or off a schedule must be done with scientific input.


Clause 12 now clarifies that reporting on releases of human pathogens and toxins does not apply to simple spills in the laboratory. It applies only to releases that actually result in these agents escaping and threatening public health.


Clause 33 no longer requires security screening for persons working with Risk Group 2 pathogens such as salmonella, while retaining the requirement for those in higher risk groups.


Clauses 38 and 39 now clarify privacy protections in the wake of suggestions made by the Office of the Privacy Commissioner.


Clauses 53, 56 and 59 now feature reduced penalties for contraventions with Risk Group 2 human pathogens. So now, except for egregious offenses, there is no possibility of prison for a first offense involving human pathogens in this group. This amendment lends greater balance to the Act, and will allow medical professionals and researchers working with more common diseases to work freely and continuously.


Finally, clause 66 provides additional scrutiny of any regulations that will be put forward following the upcoming consultations about the program and regulatory framework.


This brings me to an important point. I agree with others that Bill C-11 should be thought of as the foundation and frame of a house. With these in place, the work of deciding what fixtures and furniture might be required can be part of a separate conversation.


Once the new Act receives Royal Assent, new obligations and prohibitions will come into force. But while there will be a requirement to provide certain information to the Minister of Health, there will be no need for a license under the program in this first phase of implementation.


In phase 2, provinces, territories and stakeholders throughout the country will be consulted to develop the program and regulations framework. These are the fixtures and furniture I referred to. Consultations will cover licensing, security screening, inventories and the role and responsibilities of biological safety officers. I emphasize here that only with the Bill passed can we move forward to this critical phase of consultation.


In the third and final phase, the rest of the new Act and the regulations that accompany it will come into force. There will be ample time for stakeholders to understand and make any necessary changes so that they can follow the Act and regulations in the course of their everyday work.


I appreciate that this legislation has a defined focus and a precise scope. It calls for prudence in the acquisition, transportation, handling and disposal of pathogens and toxins. But it in no way interferes with the urgent and necessary research into cures and treatments for the diseases that sap our energy and take our lives.


This Bill wisely seeks to strengthen our system without restricting those who care for our health. This Bill is about biosafety and bio-security; it will not question or hamper research.


Only four months from today, Mr. Speaker, students will head back to colleges and universities across our country. Tens of thousands of these will be taking courses requiring that they study in laboratories where high concentrations of Risk Group 2 and even Risk Group 3 pathogens are found.


Because many of these facilities do not import human pathogen toxins, they are not yet required to follow the laboratory biosafety guidelines. While many follow them on a voluntary basis, particularly in larger institutions, the level of compliance in small labs is completely unknown.


We owe it to our students to ensure that, as they interact with containers of salmonella and Listeria and dozens of substances, there are at least basic biosafety guidelines in place to protect them.


That is a clear and present example of the immediate practical benefit of passing this Bill. Beyond that, a demonstration of our government’s wisdom and vision will give our citizens a measure of comfort and confidence as we move through the summer and into the fall with the looming threat of an influenza pandemic still very much on our minds.


This is sound legislation. This is prudent thinking. This is the Canadian consultative process at its best. I’m honored to support Bill C-11 and I invite and urge my colleagues in the Senate to stand beside me and ensure swift passage of a Bill on which the safety and security of Canadians depend.


Thank you.