Breaking News on Global Pharmaceutical Technology & Manufacturing

Canada to tighten up biosecurity laws with new bill


Related topics: Processing

Canada has bought its laboratory legislation in line with other international standards as the country proposes new legislation designed to tighten safety and access to human pathogens and toxins.

The move forms part of the country's strategy to confront the bioterrorist threat while also allowing Canada to prepare for, respond to, and recover from biological incidents. Questions have been asked of Canada's biosecurity and biosafety response after its reaction to the major outbreak of influenza in the Canadian poultry industry in 2004, and subsequently by the spread of the Asian H5N1 highly pathogenic strain from SE Asia to Europe an Africa in 2004-05. The proposed bill, unveiled last month by Health Minister Tony Clement, proposes a series of changes that establishes a mandatory licensing system to track human pathogens. In addition, the bill aims to also provide inspection powers to ensure compliance with the Laboratory Biosafety Guidelines (LBGs), and that the legislation is applied properly and consistently across the country.

Possession of certain listed human pathogens and/or toxins (smallpox is currently the one pathogen on this list) will not be permitted as will the intentional misuse of human pathogens and/or toxins to cause risk of harm. Any use of human pathogens and/or toxins without a licence will be punished. Canada's LBGs are similar to its international neighbours and were initially developed to guide government, industry, university, hospital, and other public health and microbiological laboratories in their development of biosafety policies and programs. The new revisions aim to build on existing importation regulations and establish legal authorities to ensure all work done with human pathogens and toxins is carried out in as safe a manner as possible, consistent with international standards. "This proposed legislation will bring Canada into line with other developed nations," said Clement.

"It will also make Canada's laboratory environment safer for our scientists and lab workers, and improve security for all Canadians." Concern has been expressed to the steady increase in the number of laboratories handling pathogens and in the number of scientists wishing to import into Canada new or exotic strains for further study. Should the proposed legislation come into effect Canada's laboratory legislation will be more in line with international partners such as Australia, the UK, the US tightening up legislative differences and sealing any loopholes that may have appeared.

Current Canadian law requires all labs that import human pathogens and toxins to adhere to the LBG. However, these guidelines are not mandatory although they are applied widely in labs on a voluntary basis as an industry standard.