Thank you for inviting me to speak today.
First I would like to give you a little bit of background information. I'm an infectious diseases specialist and medical microbiologist working out of the community lab situated in a hospital, the Credit Valley Hospital in Mississauga. I also have a fair amount of experience working with community or what are otherwise called private labs in the province of Ontario. I have less experience working in academic-based laboratories, but I've sought out the opinions of my colleagues in those areas in order to represent them well today.
I'm chair of the microbiology committee of the Ontario Medical Association's quality management program. This program tests proficiency amongst all licensed diagnostic microbiology labs in the province. So I have a feel for the lab work that's going on in our province with regard to diagnosis.
As you know, I'm also section head of medical microbiology in the national Association of Medical Microbiology and Infectious Disease.
Now for a little bit of background and a very high-level description of diagnostic labs in our country. The labs are based out of a number of different settings. They are based out of hospitals and community labs, most of which are privately run. And they are based out of the public health laboratories, which often serve as referral labs for work that takes place initially in the hospitals and private labs and then is brought into the public health labs for investigations of such things as outbreaks, for example.
There is a huge variation among these labs. Some labs are very, very small. They are run by a handful, literally, of people who may be trained not only in microbiology but also in chemistry and hematology, for example. Then other labs are run by hundreds of people, and they're very sophisticated, complex organizations.
The volumes of specimens will vary tremendously across the laboratories, as will the diagnostic platforms. Some labs will do some very basic microbiology, such as basic testing on throat swabs submitted to them, while others will do all sorts of testing, such as diagnostics to look for viruses, bacteria, parasites, and fungi.
This all needs to be taken into account when we study the legislation, especially considering the potential work, resources, and administrative changes that will be required of some of these labs.
The research labs can of course be based out of academic centres and public health labs as well as many private laboratories across the country. Canada has a strong reputation in research within the realm of microbiology. We see, in medical journals and international meetings, representation by our Canadian research labs in microbiology.
Bill C-11, as we all know, focuses on biosafety and biosecurity. I understand the footprint associated with biosecurity has become a bit smaller as the legislation has become more refined. It does take off from current lab biosafety guidelines published in 2004. My understanding is that the playing field is to be levelled for all labs across the country so that regulations can ensure that labs practice the same way when it comes to biosafety and biosecurity, depending on the risk associated with the pathogens being processed in their midst.
Our recommendations and concerns are as follows. I'd make a comment first, that we do applaud, of course, the focus on biosafety and biosecurity because it does reflect the culture of concern for public health. We worry, perhaps, that public health may be compromised if the program and regulatory frameworks associated with this bill are too restrictive, thereby limiting lab efforts and diagnostics and research.
So we feel that it is very important to strike a balance in the interest of preserving and improving public health, and thus have lab biosafety/biosecurity on the one hand, but also continue to produce essential research and diagnostic findings on the other hand to maintain the public health of our citizens.
When it comes to the functional application of the legislation and the regulatory framework, we're not quite sure what's in store for us. There have been information sessions that have been held by the Public Health Agency of Canada, and some questions have been addressed. But because the legislation is still fairly high-level, we're still not clear--some of us--as to what the details will entail. It does leave some of us asking if that balance of biosafety and biosecurity against advancing diagnostic research findings will remain.
We strongly feel that a good solid communications structure will need to be built in order to have this work out. A respectful, open, and bidirectional flow of information between the Office of Laboratory Security at the Public Health Agency of Canada and the key stakeholders--including AMMI Canada, my organization--will be required for this to be successfully implemented and executed.
During the development of this framework, issues like the following will require review in much greater detail.
We need to know exactly, or work together to determine, what the implementation timelines will be. We would recommend that a phasing-in of the various elements of the program occur, rather than that everything happen at once.
We need to know and discuss details of the security clearance criteria. These, of course, need to be clearly defined. And we need to discuss the impact of authorization, of keeping tabs on individuals entering and exiting labs, on the workload of laboratories versus their resources for managing it. How can this happen?
We need to know more about the nature of inventories that will be required by labs possessing various risk group pathogens. We strongly feel that tools, for example, need to be developed by the Office of Laboratory Security in conjunction with stakeholders so that people aren't inventing their own wheels to comply with the regulations.
We also feel that the Office of Laboratory Security and its key stakeholders need to discuss opportunities for maximizing efficiencies. In Ontario, for example, we're inspected by a provincial group that ensures biosafety and security. In order to import pathogens from the U.S., for example, we already fill out a questionnaire that's about 21 pages long, and it takes weeks to months, sometimes, to fill it out. So we have to ensure that in being compliant with this important legislation we're not up to the ceiling with paperwork.
Also, I think we need to further fine-tune the security requirements, depending on specific organism biosecurity risk. In the legislation we refer to risk group pathogens. I feel that even within one risk group--let's say risk group 3--there are pathogens that present varying levels of biosecurity risk. We need to refine this more so that the resulting program becomes a practical, feasible, and safe piece of legislation to work with.
In closing, I'd like to say that, again, the objective is to achieve a balance of biosafety and biosecurity within our labs while maintaining excellence in diagnostic and research efforts to promote public health. To have this occur, we need that very strong communication structure. And we need to know that the resulting regulatory framework and program are really a function of the partnership that will exist between the Office of Laboratory Security and its key stakeholders.
Thank you.