Thank you, Madam Chair.
I'm pleased to be here to discuss Bill C-313 and what it will mean to bring the regulation of non-corrective contact lenses under the authority of the Food and Drugs Act and the provisions of the medical devices regulations.
The potential risks of these types of lenses are similar to or greater than those of corrective contact lenses, and it is appropriate that these non-corrective contact lenses will fall under the same regulatory framework.
Since the definition of a device in the Food and Drugs Act relates to products that have a therapeutic or diagnostic purpose, non-corrective lenses did not fall within the meaning of this definition and therefore could not be subject to the act and regulations, as was the case for corrective lenses.
Risks with these products and the need for enhanced regulation have been raised by eye health care professionals. In 2000, Health Canada warned consumers of serious safety concerns with the use of non-corrective contact lenses and recommended use only under supervision of an eye care professional.
In 2003, a health risk assessment report, commissioned by Health Canada, confirmed that the level of risk with non-corrective contact lenses was the same as or potentially greater than with corrective lenses.
In 2005, Health Canada further acknowledged this elevated risk for non-corrective contact lenses due to direct sales to the consumer in the absence of an intermediary eye health care professional.
In 2008, Health Canada further supported the need to regulate in a previous bill, which included a deeming clause in the proposed revisions to the act so that non-corrective lenses could be regulated as a device.
Complications with contact lens use can be very serious, with some complications being sight threatening, requiring rapid diagnosis and treatment to prevent vision loss. Contact lens wear has been associated with complications such as corneal ulcers, allergic reactions, internal ocular infection, corneal scarring, and corneal abrasion.
I'd like to turn my attention now to the medical devices regulations. The regulations set out rules by which devices can be categorized into four classes based on the risk or potential harm if the product were to fail or not work according to the manufacturer's requirements.
Class I devices present the least risk and include examples such as bandages and reusable surgical instruments. Class IV, the highest-risk products, includes things like cardiac pacemakers or coronary stents.
As the class of a medical device increases in its risk, so does the level of regulatory scrutiny that Health Canada affords to the review of the product. Additionally, the regulations require manufacturers to possess objective evidence that their devices, regardless of which class they fall into, meet fundamental safety and effectiveness and labelling requirements.
If the bill is approved, non-corrective lenses would be deemed class II medical devices. It is important to note that manufacturers of non-corrective contact lenses will not have evidence of nor will they be required to attest to the effectiveness of these products as they have no role in correcting vision.
For non-corrective contact lenses, this will require that the manufacturer attest to having objective evidence for safety, that the product be labelled in accordance with requirements set out in the regulations, and that the manufacturer possess a quality management certificate, providing assurance that the product is subject to design and manufacturing controls in the manufacturing facility.
Manufacturers and importers of devices are also required to maintain distribution records, report serious problems with their devices to Health Canada after sale, have recall procedures in place, and have procedures for handling complaints concerning their products.
Once again, I thank you for the opportunity to be present here before you today. I'm open to any questions you may have.