Backgrounder of Human Pathogens and Toxins Act

The Government of Canada is committed to supporting laboratory testing and research that will promote and protect the health of Canadians. It recognizes that laboratory testing in Canada performed with human pathogens and toxins – including micro-organisms such as salmonella and the influenza virus – is vital for diagnosing the cause of diseases and for advancing science through research.  At the same time, the Government also recognizes that rules need to be in place to ensure the proper handling of such pathogens and toxins which also cause disease in humans.  Canada's approach to the safety and security of human pathogens and toxins was developed in close consultation with Canadian health and science partners active in this area and strikes a balance between these two health objectives.

Current law requires all labs that import human pathogens and toxins to adhere to the Laboratory Biosafety Guidelines, a tool developed by the Public Health Agency of Canada, in consultation with stakeholders, that promote safe laboratory practices and mitigate the risks of working with human pathogens and toxins.  These guidelines are not currently mandatory for labs that acquire human pathogens and toxins from domestic sources, although they are applied widely in these labs on a voluntary basis as an industry standard.

This proposed legislation brings Canada's laboratory legislation in line with that of our international partners, including the United States, the United Kingdom, Australia, and other countries while finding a solution that is made for the Canadian context.

The proposed Bill will establish consistency by requiring all labs in Canada, including federal, provincial and private facilities, to adhere to the guidelines.  As well, the Bill will allow for security screening of all persons accessing laboratories with dangerous human pathogens and toxins (i.e. Risk Groups 3 and 4).

Building on existing law, the Bill establishes legal prohibitions and authorities to govern the use of human pathogens and toxins in Canada.  It is designed to ensure the handling of human pathogens and toxins in Canadian laboratories is carried out in the safest manner possible while allowing research to progress.

To help ensure this safety, the proposed legislation prohibits the following:

• possession of certain listed human pathogens and/or toxins (smallpox is currently the one pathogen on this list);
• the intentional misuse of human pathogens and/or toxins to cause harm; and
• any use of human pathogens and/or toxins without a licence.

Through this Bill, the Government of Canada will be able to more easily track what human pathogens and toxins exist, where they are, and who possesses them. Working together with laboratories, the Government of Canada will be able to develop a biosafety and biosecurity program that puts in place a foundation to strengthen Canadian research while protecting the safety and security of Canadians.