Madam Speaker, today I rise to speak to Bill C-11, the human pathogens and toxins act, adopted by the Standing Committee on Health on March 31 and presented to the House on April 2, 2009. The bill is important and significant because infectious disease remains among the leading causes of death worldwide and the greatest killer of children and young adults.
Today, new infectious diseases such as HIV-AIDS, SARS and now swine influenza A(H1N1) are emerging. Old infectious diseases such as malaria, plague and tuberculosis are re-emerging, and intractable infectious diseases remain an ever-present threat. Research to combat infectious diseases has resulted in over 5,000 laboratory-associated infections and almost 200 deaths over the last 70 years. Most recently, in 2008, the Bush administration acknowledged that the Plum Island Animal Disease Center, the only U.S. facility allowed to research highly contagious foot-and-mouth disease, experienced several accidents with the virus.
Fortunately, Canada has not experienced a large intentional or unintentional release of a dangerous agent. However, we have had some close calls. In April 2005 a facility in Canada imported a live virus sample under a risk group 2 permit. However, laboratory analysis showed that the material was contaminated with a risk group 3 pathogen: namely, influenza A(H2N2). Once the contamination was confirmed, the Public Health Agency of Canada's importation office, in consultation with the World Health Organization, the U.S. Centers for Disease Control and the provincial health ministers contacted the supplier of the material and all facilities in Canada that had been issued a permit for the same panel and advised them of corrective action.
It was only because the material was imported that the federal government was able to track who had the affected materials. Should this situation happen today in Canada, with a domestically produced product, there would be no authority or ability to track materials and advise affected parties of corrective action. This could result in a biosafety and biosecurity risk as Canadians would likely have no immunity to the influenza A(H2N2) virus, possibly creating the conditions for the next influenza pandemic. This is why the legislation is so important.
Currently, PHAC has knowledge of laboratory-acquired infections, but has no national reporting mechanism to capture them. Our laboratories must have strict facility safeguards, microbiological practices and safety equipment to protect laboratory workers, the environment and the public from exposure to infectious micro-organisms and toxins that are stored in the laboratories. We must ensure the safety of all Canadians.
Therefore, we must be diligent in creating a legislative base that balances biosafety without impeding scientific advancement. We must also provide assurances to the Canadian public and our international partners that Canada takes biosafety and biosecurity seriously.
Bill C-11 will only succeed in making Canadians more secure if the scientists it regulates are consulted thoroughly and if the bill is implemented in close partnership with them. Canadian economic and social prosperity depend on scientific study. We must be wary of a regulatory regime that would interrupt discovery, as happened in the United States following publication of similar legislation. Many laboratories simply stopped working with listed pathogens rather than face the costs and hassles of complying with the legislation.
I believe Bill C-11 strikes the necessary balance between mitigation of risk and scientific freedom, which must then be maintained in the regulations. This balance will require, in the words of one witness, “constant attention and rebalancing that can be done only through ongoing dialogue with the scientific community”.
Witnesses from PHAC assured the committee that consultations will help determine what the regulations regime will look like. Witnesses were optimistic that they could move forward together with partners and that they would continue to take action to address their concerns.
The committee recommended the creation of an external advisory group, perhaps consisting of representatives from private industry, provincial public health agencies, universities and others to ensure that the regulations and the subsequent implementation of the bill proceed with the input and the support of the scientists.
The proposed external advisory group could also be instrumental in categorizing pathogens, as there was discussion regarding, for example, whether or not certain risk group 2 pathogens should be removed from the schedule. Removing risk group 2 from the legislative framework would take away the ability to know who has those pathogens, which are the majority of pathogens in Canada, the ability to assess whether they are handled in an appropriate manner and the ability to measure laboratory-acquired infections and their impacts.
There was general agreement that risk group 2 should be handled in a safe manner, which is not necessarily happening now, but less stringently than risk group 3.
Witnesses from PHAC also addressed stakeholder concerns regarding financial expenditures. It was pointed out that these costs must be balanced against the cost of taking no action, mainly loss of credibility, dollars and human life, which are significant in this case.
Other stakeholder concerns included duplicate laboratory licensing regimes, security checks, licences and privacy issues. The potential for duplicate regulatory licensing and inspection regimes is significant, as is the possible impacts on workload and scheduling which could drastically affect the operation of clinical, public health and research laboratories.
Witnesses from PHAC agreed that opportunities for harmonizing licensing with existing regimes must be considered. Witnesses from PHAC also agreed to clarify the requirements for security clearances for different categories of workers.
Security checks were thought to be burdensome by stakeholders due to significant impacts on students and training, as well as the lab's ability to hire additional staff during an outbreak. Stakeholders would like PHAC to clarify who the inspectors will be, how they will be trained and how they will carry out their tasks.
Partners would also like PHAC to address the important issues regarding licensing. For example, to whom a licence should be awarded, the institution, the group or the individual? What conditions will be required for awarding licences? Will there be an appeals process? Will custodial staff have access to labs? Will they require security clearances?
The last concern I will address is that of privacy, as clause 38 of the bill identifies extremely broad powers for the minister to order an applicant to disclose personal information. It is the committee's understanding that conversations have taken place with the Privacy Commissioner to satisfy stakeholder unease.
I would like to draw attention to the fact that strengthening global surveillance is not enough to eliminate or eradicate infectious disease. We need close ties among public health, trade and transportation organizations. We also need better collaboration with those monitoring the biological weapons convention, because bioterrorism remains a very real threat.
In 2004, The National Academies committee issued a report entitled, “Biotechnology Research in an Age of Terrorism”. The report identified experiments of concern, such as rendering vaccines ineffective or turning non-pathogens, which are not found anywhere in the bill's schedules, into pathogens.
We need to ensure that granting agencies and medical journals are sensitive to these matters and have processes for addressing them. The same National Academies committee recommended creating, through legislation, an independent science and technology advisory group to the intelligence community. Does such a group exist in Canada to monitor and study the next generation of threats in a comprehensive, systematic way, as is being undertaken in the United States?
Finally, the bill is only part of the web of protection needed to make Canada more secure and prepared for bioterrorism. What is being done to promote a common culture of awareness, a shared sense of responsibility to prevent misuse within the scientific community?
We need more than legislation. We need a code of ethics, role modelling and teaching with a particular focus on the biosecurity agenda in Canada.
We have had multiple wake-up calls. Complacency cannot be an option when it comes to biosafety and biosecurity, which is why this legislation is important. The committee did work hard together to make necessary modifications to the bill.