Debates of the Senate  
2nd Session, 40th Parliament,Volume 146, Issue 40.
  Tuesday, June 2, 2009
 
Orders of the Day: Human Pathogens and Toxins Act, Bill C-11
On the Order: Resuming debate on the motion of the Honourable Senator Eaton, seconded by the Honourable Senator Gerstein, for the second reading of Bill C-11, An Act to promote safety and security with respect to human pathogens and toxins.

Hon. Lillian Eva Dyck: Honourable senators, I rise today to speak to Bill C-11, an act to promote safety and security with respect to human pathogens and toxins. Let me begin by saying that it is clear from the transcripts of the debates in the other place and from the committee report on this bill that Bill C-11 was seriously considered and studied in-depth by individual members and by the Standing Committee on Health. Bill C-11 has been improved significantly by a number of amendments introduced in the other place.

The purpose or intent of this bill is to establish a bio-safety and bio-security framework that allows for the safe handling of human pathogens and toxins. It is intended to protect the health and safety of Canadians from infectious diseases resulting from the production, transport and physical manipulation of human pathogens and toxins.

Bill C-11 sets up a system of classification of these substances based on the severity of health risks associated with a particular substance. Appended to this bill are schedules of substances classified by the severity of the level of risk to human health and by the type of substance such as bacteria, viruses and prions. For example, listeria monocytogenes and Colorado tick fever virus are listed in Schedule 2 as low-risk agents while West Nile Virus which you recall swept across the country a few years ago is included in Schedule 3 because it has more severe health effects on humans. Ebola virus is located in Schedule 4 with more severe health risks, and smallpox virus is under Schedule 5, the prohibited pathogens and toxins.

Honourable senators, it is not hard to imagine that with new scientific discoveries and new emerging strains of infectious agents, such as the influenza A H1N1 virus, that these schedules cannot be fixed in stone. They must be amended from time to time. Bill C-11 sets up the process to do that in sections 9 and 10. In consultation with an advisory committee established under the Public Health Agency of Canada Act, the Minister of Health may add to or delete items from the schedules of pathogens and toxins. This allows the schedules to be responsive to public health concerns over new strains of viruses emerging in Canada or elsewhere.

Bill C-11 will also protect the health and safety of those individuals who actually handle these substances as part of the activities associated with their occupations. It is likely that this latter group is at greater risk than the public at large in most instances. For example, research technicians, research scientists and trainees who manipulate these substances in their laboratories will be better protected with the implementation of Bill C-11.

There are big gaps in the current legislation that Bill C-11 will fix. Though there are legislative regulations concerning the importation of human pathogens and toxins, there are not any concerning their domestic transport within Canada. Consequently, those laboratories that acquire toxins and human pathogens domestically are not required by law to follow bio-safety guidelines, but do so voluntarily. This situation creates a potential safety hazard for those who work in unregulated laboratories, for those involved in the domestic transport of human pathogens and toxins and for the public at large.

Honourable senators, imagine that you are a director of a research facility and you wish to carry out experimental investigations on West Nile virus. It would make no sense to you that different rules apply, depending on whether you obtained it from Canadian sources or from another country. That situation currently exists.

Bill C-11 will change this situation so that there is a uniform licensing system nationally, which not only makes sense but also means that there will be greater safety for everyone. Once enacted, Bill C-11 will allow for a complete national database of the locations of human pathogens and toxins. Presently, only the locations of imported agents are known.

Bill C-11 outlines a comprehensive system for obtaining a licence to conduct controlled activities with human pathogens and toxins. The types of controlled activities are listed in section 7. Thus, for example, a research scientist would be able to obtain a licence to acquire human pathogens and toxins, except for those that are prohibited and listed in schedule 5; and that research scientist would be able to conduct controlled activities or experiments that comply with the regulations to be developed according to this bill.

Honourable senators, once again, imagine that you are the director of a research facility after this bill comes into force. Imagine that you have already obtained a licence so that you can conduct experiments utilizing a particular human pathogen. To ensure the safety of the general public and those people who work with the particular pathogen, you would be required to appoint a biological safety officer who would be responsible for overseeing the work with that substance in your laboratory. In addition, there would be, from time to time, an inspector who would come to your facility to confirm that the procedures occurring within your laboratory were conducted according to regulations that is, in a safe manner.

There is the possibility, rare I suspect, that somehow shortcuts have been taken in the procedures that are being conducted by you or someone else in the laboratory, and that these shortcuts create an unsafe condition. That is why having an external inspector check over the lab records, inventories, notebooks and day-to-day hands-on procedures is most useful. Such inspections are a reminder to be vigilant about good laboratory practice, and official inspections will likely verify that such is the case in the vast majority of instances.

While this approach may seem to be a rather odd process, which could be construed as a policing system, the process is not unusual for those who work in laboratories. For example, a similar system occurs for those who work with radioactive compounds. This type of inspection ensures the safety of the laboratory personnel and the general public at large.

For those laboratories, however, that have not been so regulated, it may be seen as an undue burden to comply with this system outlined in Bill C-11. However, a balance must be achieved between scientific freedom and public safety.

Under Bill C-11, clauses 40 to 52 describe the administration and enforcement of the act. For example, if an inspector finds that things are done in a manner that poses a serious and imminent danger to the health and safety of the public, the inspector can order remedial actions be taken to reduce or eliminate that danger.

Clauses 20 to 22 of the bill outline the process whereby the minister can suspend or revoke a licence, and clauses 24 to 29 outline the processes for appealing such a decision.

Honourable senators, imagine the worst case scenarios, where the public health and safety has been endangered for example, where a person has knowingly conducted activities with prohibited substances listed in schedule 5, or situations where a person has intentionally released a human pathogen or toxin. A system of fines and possible imprisonment is outlined in clauses 53 to 64, the severity of which is directly correlated to the risk associated with the type of pathogen or toxin involved in the offence.

In other words, honourable senators, the fines and lengths of imprisonment increase with the increasing level of risk to the public health caused by the particular pathogen. For example, an offence related to risk group 2, which includes substances that pose a moderate risk to the health of individuals and a low risk to public health, carries a lower penalty than an offence related to risk group 4 substances, which pose a higher risk to an individual and a high risk to public health.

Honourable senators, imagine that you are a member of the general public and you wish to see what is happening in the National Microbiology Laboratory in Winnipeg, which has a level 4 safety rating, the highest level. In this facility, scientific staff members are able to conduct work on human pathogens and toxins at the highest level of risk to human health and safety permitted.

Some years ago, as a member of the Science Advisory Board of Health Canada, I visited this facility. To do so, like every person who enters that facility, I had to receive a security clearance. This security makes eminent sense to me, as not everyone should have potential access to highly infectious and highly dangerous pathogens and toxins. Clauses 33 to 35 of Bill C-11 outline the procedures relevant to obtaining a security clearance from the Minister of Health to enter a facility that conducts activities with human pathogens that fall into risk groups 3 and 4.

Honourable senators, no doubt you are imagining how complicated the system must be to regulate the types of controlled activities, the types of facilities such as laboratories, the types of administrative processes, the qualifications of a licence holder, the biological safety officer, the inspector, the biosafety guidelines and so on. The processes whereby these regulations will be developed are described in clauses 66 to 69. These clauses were significantly amended in the other place to incorporate the level of risk associated with the human pathogens and toxins, and the process whereby the proposed regulations are to be reviewed by both houses of Parliament.

Bill C-11 will be implemented in three phases. After Royal Assent, the first phase requires every person who has a human pathogen or toxin to inform the Minister of Health, and in the case of schedule 5 agents, which are the most dangerous, to dispose of any according to the minister's instructions. The first phase allows the minister to know who has what pathogens and toxins and where they are located, and allows for the disposal of the most dangerous agents.

In addition, the clauses dealing with prohibited activities, offences and penalties and other provisions, except those under clause 7, which outline the controlled activities that are prohibited unless licensed to do so by the minister, will come into force.

The second phase of implementation of this bill is to develop the regulatory framework. The third phase provides a timeline for stakeholders to come into compliance with the bill.

Honourable senators, Bill C-11 has been reviewed and debated in depth in the other place. There were seven committee hearings in the other place; there were five government witnesses and 13 other witnesses that appeared before the committee, and numerous debates.

Of particular note are the significant amendments that were made to the bill to address concerns related to important clauses of the bill, some of which I have already mentioned, such as the incorporation of clauses that direct the Minister of Health to consult an advisory committee before making any changes to the substances listed in the schedules.

Concerns with respect to the Privacy Act were expressed at third reading. It was suggested that this house of sober second thought and the review committee give these concerns further consideration. Nonetheless, the bill was passed in the other place with a resounding majority.

Honourable senators, Bill C-11 is a sound and important piece of legislation that balances the need for ensuring that the safety of all Canadians is not compromised by the activities associated with the production, transport, handling and disposal of human pathogens and toxins. It closes significant loopholes in current legislation and it proposes a national system of regulation that meets the standards of other countries, such as the United States of America.

The Hon. the Speaker: Is it your pleasure, honourable senators, to adopt the motion?

(Motion agreed to and bill read second time).

Referred to Committee

The Hon. the Speaker: When shall this bill be read the third time?

(On motion of Senator Comeau, bill referred to the Standing Senate Committee on Social Affairs, Science and Technology.)