Good afternoon.
My name is Stéphane Lévesque, and I am the general manager of the Groupement provincial de l'industrie du médicament, which represents the SMEs working in Quebec in the production and commercialization of drugs and natural health products, including disinfectants and biocides.
I have scientific training and 29 years' experience in the pharmaceutical field. I am very familiar with the role of disinfectants, particularly in combating the C. difficile bacterium, which is a cause of infections in hospital facilities.
Health Canada's proposed regulations will not solve the problems detected and will even result in excess work for government officials in the coming years.
There are valid reasons to question the actual intent of this regulatory framework. Products approved in the United States will not be regulated as strictly as those manufactured in Canada, which will thus result in a double standard that will work to the detriment of Canadian SMEs. This framework will not improve the productivity of Health Canada's review team but rather will result in additional delays in the approval process for our manufacturers.
Health Canada's natural and non-prescription health products directorate has tried for years to meet its own approval standards for disinfectants. Only a portion of Canadian marketing licence applications would be approved on the first round, compared to those submitted for American disinfectants, which would be approved immediately.
There must be no increase in the size of the bureaucracy. Lastly, our opposition to these proposed regulations concludes with a call for a moratorium for the purpose of determining their impact on the Canadian industry.
If the proposed regulatory framework were adopted in its present form, Health Canada would favour American businesses over Canadian businesses, most of which are SMEs.