Health Committee on Feb. 14th, 2012

[The Chair, Conservative, Joy Smith]

Today we are studying Bill C-313, An Act to amend the Food and Drugs Act (non-corrective cosmetic contact lenses).

We're very pleased to have with us here today the sponsor of the bill, Ms. Patricia Davidson, from Sarnia—Lambton. From Health Canada, we have Mr. Don Boyer. From the Canadian Association of Optometrists, we have Mr. Dana Cooper and Dr. Desmond Fonn. It's nice to see you. From the Canadian Ophthalmological Society, we have Mrs. Jennifer Brunet-Colvey, executive director and CEO, and Dr. Peter Agapitos, chief of the Department of Ophthalmology at the Ottawa Hospital. And from the Opticians Association of Canada, we have Mr. Lorne Kashin and Ms. Janice Schmidt. Welcome.

We're very tight for time right now.

Ms. Davidson, would you like to begin your 10-minute presentation?

[Patricia Davidson, Conservative, Sarnia—Lambton, ON]

Thank you very much, Madam Chair. It's with great respect that I accept your invitation to appear before the health committee in order to give testimony in support of Bill C-313, An Act to amend the Food and Drugs Act in relation to non-corrective lenses.

I'd like to share with the members that I was a member of this committee in the past. I sat with some of you on this very committee, and I recall the important work that was accomplished. I'd like to commend each of you for the work you do and the manner in which issues are effectively dealt with at the health committee.

It was through my work on this committee several years ago that I was made aware of the growing concerns created by the unregulated use of non-prescriptive cosmetic contact lenses. For the purposes of this bill, we shall call these lenses non-corrective lenses. But to be clear, I am referring to the types of lenses that are not prescribed by eye experts. I am referring to non-prescriptive lenses like cat eyes or vampire eyes. These lenses are used by consumers with little to no understanding of the damage being done to their own eyes. Such lenses can be ordered online or bought over the counter at various stores in Canadian communities.

As I said, it was my work on this committee that led to a further understanding of the issue at hand. We had numerous calls from the eye care industry, calling for Health Canada to step in and regulate the growing industry of non-prescription, non-corrective lenses.

After consultations with leading eye care industry stakeholders, I began work on my own private member's business, stemming from the research I had conducted. I had the opportunity to present motion M-409 in the 39th Parliament, which was unanimously supported in the House of Commons. Prior to the 2008 election being called, the Government of Canada had included the measures called for in my private member's motion to be enacted via government legislation. However, the election call meant that this work was left unfinished. It remained low on the list of priorities for PMB when the 40th Parliament resumed. However, as my name began to near the top of the list, I once again turned my attention to attempting to bring non-prescriptive lenses under some form of federal regulation and I began crafting what we now see as Bill C-313.

In the 41st Parliament I was given an opportunity to be near the top of the list for private members' business, and since my re-election I've been quite busy finalizing my bill in order to present it to the House. In light of the introduction of Bill C-313 in the 41st Parliament, I have once again been impressed with the work of my colleagues from all parties—they have seen this issue as a true health concern for Canadian consumers and have again pledged their unanimous support to Bill C-313.

At both first and second readings, I was buoyed by the positive remarks from all sides of the aisle towards my legislation. With that in mind, I am quite keen to continue this discussion with you today.

I would like to present a few brief facts on non-corrective contact lenses. It is now an established scientific fact that national distribution of non-prescriptive contact lenses without professional oversight, fitting, and training significantly increases the risk of public harm. Today we know the warnings on cosmetic lenses dating back to October 23, 2000, by Health Canada were well warranted. We now require legislation to alleviate the potential harm that could be done to consumers of these products.

To some, it may seem that to deem a decorative lens as a harmful product is somewhat overreaching, yet eye care professionals and medical researchers have shown otherwise. A short list of the complications that could occur from unsafe handling and wearing an improperly fitted lens includes the following: conjunctivitis, cornea abrasions, giant papillary conjunctivitis, microbial keratitis, and other forms of bacterial, allergic, and microbial infection as specified by the eye care industry. Some of our youth are even sharing these lenses with one another, if you can believe that. Already we know that all these complications occur with prescribed lenses, which is exactly why Health Canada regulates the use of these products through opticians and regulatory bodies.

What has been shown as fact through peer review studies is that non-prescribed decorative or cosmetic lenses are much more likely to cause complications to users. This is true for a combination of reasons, including lack of consumer information on the quality of the product and how to use it. To date, we have seen several studies on decorative lenses and the harm they can cause to consumers.

Perhaps the most well known study in Canada is the human health risk assessment of cosmetic contact lenses conducted by Dillon Consulting Limited, also known as the Dillon report. The final assessment was submitted to Health Canada in September 2003, and it outlined the scientific evidence, which at this point was still being debated by public health officials:

The level of risk associated with the use of cosmetic contact lenses is comparable to that associated with corrective lenses and may be potentially higher.

In addition, research conducted at Department of Ophthalmology at Strasbourg University Hospital in Strasbourg, France, clearly indicates, and I quote from the conclusion of that study:

Patients who acquire [cosmetic contact lenses] are less likely to be instructed on appropriate lenses use and basic hygiene rules. Consequently, [cosmetic contact lenses] wearers are experiencing acute vision-threatening infections.

There is no reason to believe that the situation is any different in Canada. In fact, the Dillon report of 2003, which in many ways served as a ground-breaker on this issue, also came to the same conclusions as the French study in 2011.

Colleagues, I feel it is essential that we work together on this important issue to ensure that the eye health of Canadians is protected. I feel that under the current regulatory regime there is no oversight on these non-corrective cosmetic lenses, and in fact there could be many Canadians placing their vision at risk. We have a chance to work together on this legislation to ensure that the concerns of the eye care industry are taken seriously, and that we also take Health Canada's own warnings on non-corrective cosmetic lenses seriously as well. It is time to bring them under the same regulations as prescriptive contact lenses, and I believe this is the proper recourse for us as policy-makers to consider.

I thank those of you who spoke in support of Bill C-313 in the House, and I thank each of you for your time here now. I'm prepared to answer any questions, Madam Chair.

[The Chair, Conservative, Joy Smith]

Thank you, Ms. Davidson.

We'll now go to the Department of Health and Don Boyer, please.

[Don Boyer, Acting Director, Medical Devices Bureau, Department of Health]

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.

[The Chair, Conservative, Joy Smith]

Thank you, Mr. Boyer.

We'll now go to the Canadian Association of Optometrists, Mr. Dana Cooper.

[Dana Cooper, Director, Government Relations and Public Affairs, Canadian Association of Optometrists]

Good morning, and thank you, Madam Chair and health committee members. We thank you for allowing us to appear in support of Bill C-313 to classify non-corrective cosmetic contact lenses as class II medical devices. We would also like to express our appreciation to Patricia Davidson, MP for Sarnia—Lambton, for bringing this important issue to the attention of the House of Commons and all Canadians. Thank you.

The Canadian Association of Optometrists represents almost 5,000 doctors of optometry in Canada. Doctors of optometry represent independent primary health care providers who specialize in the examination, diagnosis, treatment, management, and prevention of diseases and disorders of the visual system.

The issue of classifying non-corrective cosmetic contact lenses as medical devices has already been a very long road. It is our sincere desire to see this part of our journey for regulation of these devices come to an end with all-party support. A reason for pursuing this legislative change is simple: contact lenses are medical devices for good reason. There is a risk of harm associated with placing a device in direct contact with one of the most delicate and sensitive organs of the human body, the eye. In this context, there is literally no difference and even a greater risk between contact lenses that correct vision and those that provide purely aesthetic changes such as non-corrective contact lenses.

This was acknowledged in September 2003 by Health Canada's own study entitled “Human Health Risk Assessment of Cosmetic Contact Lenses”. This report concludes by stating:

...Health Canada may wish to consider placing restrictions on the manner in which these products are sold to the consumer, such as requiring prescriptions for their use and/or restricting their sale to regulated eye-care professions.

This is the journey that vision health professionals are on. Since the Health Canada report was issued, the availability and awareness of these products have increased considerably. While we do not have sales figures to support this claim, one only has to look at activity in the marketplace to get a sense of the growth of this market. Some of these clues include the number of Internet sites offering cosmetic contact lenses; the number of media articles regarding cosmetic contact lenses and the complications associated with them; the activity in Europe, Asia, and North America by opticians, ophthalmologists, and optometrists pursuing better controls; and increasing activity by the same professional groups in issuing annual warnings about decorative contact lens use and educating consumers and parliamentarians.

Bill C-313 is a common-sense initiative that aligns all contact lenses in the same federal regulatory environment. Bill C-313 makes sense from a vision health perspective, a consumer protection perspective, and is justified based on the concerns and actions already taken and being pursued by governments around the world.

Achieving royal assent for Bill C-313 is only part of the journey. Bill C-313 is the impetus for vision health professionals to encourage adjustments to provincial regulations to also place non-corrective cosmetic contact lenses in the same regulatory environment as corrective contact lenses. It is at the provincial level where prescribing and dispensing regulations rest, and this is the level of regulation that makes sense for non-corrective cosmetic contact lenses.

I will take this opportunity to provide the committee members with a broader perspective with regard to vision health. Canada is at the thin edge of the wedge with regard to a vision loss crisis that will see the incidence of vision loss more than double within the next 20 years. The four major causes of vision loss in Canada are all age-related, and as we know, we have an aging population. I'm sure my colleagues will agree that increased emphasis and priority needs to be placed on vision health. This issue of non-corrective contact lens regulations is a step in the right direction toward a larger objective of developing a national vision strategy that will deal with standards of vision care and issues common to the people of Canada from coast to coast to coast.

Vision health needs a higher priority for many reasons, including the fact that vision loss is the most feared disability for Canadians. In 2007, vision loss had the highest direct cost to health care of any disease. The incidence of vision loss will more than double in the next 20 years, and 75% of vision loss is preventable.

We ask committee members to support our efforts by endorsing Bill C-313 and help us take this step towards the higher priority that vision health must take for all Canadians.

I would like once again to thank the committee for allowing us to be here today, for the support of Bill C-313, and for their awareness of vision health as an increasingly significant consumer health issue.

Thank you.

[The Chair, Conservative, Joy Smith]

Thank you for your very insightful presentation, Mr. Cooper.

We'll now go to Ms. Jennifer Brunet-Colvey.

[Jennifer Brunet-Colvey, Executive Director and Chief Executive Officer, Canadian Ophthalmological Society]

Thank you very much.

I would like to thank Madam Chairperson and members of the Standing Committee on Health for allowing us to present this morning, and also to convey our deep appreciation to Patricia Davidson, MP for Sarnia—Lambton, for bringing forward this most important issue.

Before I turn it over to our expert witness, Dr. Peter Agapitos, I want to provide you with a very brief overview of what the Canadian Ophthalmological Society is.

The Canadian Ophthalmological Society, or the COS, is the principal national public voice for ophthalmology in Canada. COS is the national organization representing all of the eye physicians and surgeons in Canada. Our mission is to ensure the provision of optimal eye care by promoting excellence in ophthalmology and by providing services to support our members in practice.

We're an affiliate of the Canadian Medical Association, the CMA, and an accredited provider of continuing professional development or continuing medical education, as recognized by the Royal College of Physicians and Surgeons of Canada.

COS works to improve eye and vision care standards for all Canadians through the work of our board of directors, our councils and committees, and ties with national and international ophthalmological and eye care organizations. We have over 1,000 ophthalmologists who are members of the COS and 200 residents in ophthalmology who are also members.

I would now like to turn it over to Dr. Peter Agapitos.

Thank you.

[Dr. Peter J. Agapitos, Representative, Canadian Ophthalmological Society, and Chief, Department of Ophthamology, Ottawa Hospital]

Madam Chairperson and members of the Standing Committee on Health, thank you for allowing me today to address you on this important issue.

I would like to express at this time my gratitude to Ms. Patricia Davidson, MP for Sarnia—Lambton, for bringing the issue of non-corrective cosmetic contact lenses to the attention of the House of Commons.

As an ophthalmologist who specializes in corneal diseases and surgery, I regularly see in my practice contact-lens-related corneal infections. These infections may cause irreversible damage from corneal scarring, sometimes necessitating corneal transplantation. Non-corrective cosmetic contact lenses are also prone to these same complications and are no different from other contact lenses in this regard.

At the outset, a patient seeking vision corrections with contact lenses requires an eye care professional, an ophthalmologist, optometrist, or optician, to examine them carefully in order that a determination be made as to the feasibility of contact lens wear. Many diseases or conditions may make contact lens wear unsafe, and patients may be unaware that they have these conditions. For example, dry eyes or certain medications that are common in young people, such as accutane for treatment of acne, among others, may make contact lens wear unsafe and inadvisable.

Once the patient's ocular health has been found to be suitable, then a recommendation on the type of contact lens can be made. Subsequent to this, a properly fitting contact lens is required. The patient needs to be capable of adhering to a proper wearing schedule, and proper disinfecting procedures also need to be learned and followed by these patients. Close follow-up after initial fitting will allow for the observation of any ill effects.

Patients who purchase non-corrective contacts on the Internet or from retail outlets without the benefit of interaction with an eye care professional and proper instruction as to wearing schedules and disinfection procedures are at high risk of corneal infections. As Ms. Davidson has pointed out, there are recent studies to suggest that they are even more prone to infections and complications.

Corneal injury from contact lenses is a significant public health issue in Canada. The incidents may be as a high as 0.5% to 1% in contact lens wearers. This would include microbial keratitis or corneal infections, corneal abrasions, which may lead to infections, and growth of new blood vessels in the cornea from hypoxia or lack of oxygen. When these complications occur and loss of vision ensues, the morbidity is truly catastrophic.

Personally, the most unfortunate patient that I have seen was a young woman who wore contact lenses overnight and developed bilateral central corneal ulcers from an aggressive bacteria. This caused central corneal scarring and poor vision, and it caused her to require corneal transplants at a young age.

Other countries, notably the United States, are ahead of us with this issue, having passed appropriate legislation in the year 2005.

I would ask that this committee recommend that Bill C-313 be passed in the House of Commons.

Thank you very much for allowing me to present this brief to you today. I'd be happy to entertain any questions.

[The Chair, Conservative, Joy Smith]

Thank you.

Dr. Fonn, we weren't informed, but I understand you have a presentation you'd like to give to us as well. Seeing as you are the founding director of the centre for contact lenses, I think that would be a very useful presentation.

If you don't mind, could you give us a five-minute presentation?

[Dr. Desmond Fonn, Representative, Canadian Association of Optometrists, and Founding Director, Centre for Contact Lens Research, University of Waterloo]

Thank you, Madam Chair, and of course the committee.

I'd prefer to speak to you as an optometrist, although still representing the Canadian association, and not only as an optometrist but also as a researcher, as editor-in-chief of Eye and Contact Lens, which is the official journal of the Contact Lens Association of Ophthalmologists, as a parent, and as a grandparent. This is an appeal. My statement is there without reiterating the eloquence of Pat and others about this issue and why it's absolutely essential that this bill gets passed.

These contact lenses, which are designed to change the appearance of the eye, are no different from any other contact lens in that they bring with them at least the same risk as does any contact lens when you apply it to the eye. But these lenses are different. They're different because we don't know anything about them. There are so many different designs, so many different materials that are used. We don't know the manufacturing standards for these lenses. We don't know how they fit to the eye or whether they conform or not. We don't know how these lenses are worn by people. There are so many unknowns. All of those bring added risk to individuals who wear these lenses without the guidance of eye care professionals, and that's very serious.

We know through research that we and many others have done, which has been published in the last few years, that patients who are instructed are non-compliant. Imagine people who have no guidance or no instruction on how to use these lenses and how they might think they can wear these lenses safely. They are not safe at all for that reason alone. These children, these adolescents, believe they're invulnerable, that nothing can harm them. What about when they drive at night with these lenses and these lenses are not used as corrective devices? A person who normally needs vision correction takes their glasses off and puts these lenses on. Whose liability does that become then?

There is a risk for developing not only serious complications. Microbial keratitis and its associated morbidity pale in comparison to what can happen if you have intraocular infection: the loss of the eye, enucleation, or worse. So there's every good reason to place these lenses in the hands of people who can dictate how patients or how people can use them.

The most recent research shows unequivocally that these lenses bring greater risk. People who are not instructed on how to use lenses and who don't disinfect or clean them or who use tap water on their lenses will unquestionably have far greater risk of developing serious ocular complications. So I appeal to you to pass this bill.

Thank you.

[The Chair, Conservative, Joy Smith]

Thank you very much, Doctor.

We'll now go to Mr. Lorne Kashin from the Opticians Association of Canada.

[Lorne Kashin, Vice-President, Opticians Association of Canada]

Thank you, Madam Chair.

We'd like to thank the committee for giving us the opportunity to participate in the support of Bill C-313, which will reclassify cosmetic contact lenses as class II medical devices. We'd also like to thank Member of Parliament Patricia Davidson for bringing this bill forward.

The Opticians Association of Canada is a non-profit organization, representing approximately 6,000 opticians, with the objective and purpose of representing the common interest of dispensing opticians in Canada and of promoting and increasing, in the public interest, the delivery of the highest quality of products and services provided by our members.

The Opticians Association of Canada appears today before the House committee in support of the private member's bill, C-313, An Act to amend the Food and Drugs Act. The OAC concerns itself greatly with the eye health and welfare of Canadians. We consider ourselves part of the model of collaborative eye health. To this end, we speak today to this committee of the dangers associated with wearing non-corrective cosmetic contact lenses and the need to regulate this potentially dangerous product.

Although non-prescription cosmetic contact lenses appear to be innocuous and amusing, they carry the same risk factors as a prescription contact lens when the individual is not properly fitted and educated on contact lens wear and maintenance. There is also the need for the wearer to understand the importance of the monitoring of ocular health by a licensed eye care professional. We intend here today to show the importance and relevance of properly fitted contact lenses by an eye care professional.

Contact lenses are not one-size-fits-all, and there is a whole range of ocular problems associated with improperly fitted lenses. Based on many cases reported by eye care professionals, severe eye complications have been reported with as little as one wearing of these lenses. Consumers need to know there is a great deal of maturity, responsibility, and awareness required with contact lens wear, whether they are used for vision correction or not. Beyond any doubt, improper use of non-prescription cosmetic contact lenses can be detrimental to your vision, and in some cases can result in permanent vision loss.

Cosmetic contact lenses can be fun and entertaining, provided they are procured through a regulated eye care professional, who will ensure your eyes stay healthy and protected.

Thank you. I'd like to defer to my colleague Janice Schmidt.

[Janice Schmidt, Advisor, Opticians Association of Canada]

Thank you.

Good morning, everyone. On behalf of all eye care professionals, I would like to again echo everyone's thoughts that all contact lenses should be considered medical devices, whether they are prescription or non-prescription.

Obviously, the purpose of our position statement today is to thank you again and to support Pat Davidson. In the opinion of the House, the Minister of Health should regulate non-corrective cosmetic contact lenses as medical devices.

I would like to bring up two key points. My first point is regarding anatomy and physiology.

I'd like to start by saying that all corneas are not created equal. Few corneas are spherical, and the average cornea flattens from the apex to the periphery. All eye care professionals measure corneal curvature with a keratometer, and we use this particular instrument to determine the corneal curvature and therefore the fitting or the selection of the base curve. Corneas vary. Contact lens base curve selection varies. And these choices are absolutely necessary to customize the fitting of the contact lens to the patient.

Manufacturers of prescription contact lenses are aware of the differences in corneal curvature, so they provide a wide range of products and lens parameters for eye care professionals from which to choose. Once we have selected the correct base curve, once we have fitted the contact lens, it is then our responsibility to monitor the cornea-contact lens relationship, always keeping in mind that it is the corneal integrity and the health of that person's eye that we have to maintain.

The sale of plano cosmetic contact lenses by unauthorized persons has resulted in poorly fitted lenses in the past, and will continue, if we don't move forward. What that means to me as a contact lens fitter is either the lens is going to be fitting too flat or the lens is going to be fitting too steep, which means too tightly. The ill-fitting contact lens is going to result in complications due to hypoxia, which is a reduction in oxygen to the corneal tissue and surface, or to anoxia, which is an absolute reduction in oxygen. This manifests itself on behalf of the patient as marked reduced visual acuity, number one, and corneal edema.

The reason we see so well is that the cornea, or the window of the eye, is transparent and allows the light to pass through. As soon as you get corneal edema, you lose your corneal transparency, your visual acuity is reduced, and on top of that, you get a breakdown in surface epithelium. As a teacher, I am fully aware of the fact that an intact surface epithelium is our best defence against a major corneal event.

At this point I am hoping, through all these presentations, that we all know that every person is unique in terms of corneal topography and tear chemistry. I believe it is the responsibility of eye care professionals to consider all these factors when it comes to selecting the contact lens, the modality of wear of the contact lens, and finally, even the selection of the contact lens solution. Therefore, to me, moving forward with this bill will put the dispensing of non-corrective contact lenses back into the hands of the eye care professional, where it really should be.

My second point, just very quickly, is the demographic target market, which is the teens and tweens. Tweens are children between childhood and adolescence, usually ages 8 to 12. This is the emergence of a totally new market that will in time become our future adult Canadian consumers. Most of the plano cosmetic contact lenses are marketed to this particular age group.

This is a market of pre-adolescents who are maturing very quickly. I don't know about you folks, but the 10-year-olds of today are certainly a lot more mature than they used to be in my day. They're very anxious to develop and cultivate a sophisticated self-image. They know fashion. They know trends. They seek role models.

I believe that if Justin Bieber came out with a whole set of cosmetic contact lenses, thousands of young girls and boys would purchase them. The media messages today suggest to these girls and boys what it is like to grow up in today's world. This makes them so vulnerable to sophisticated marketing plans.The need to move forward and protect the eye care of Canadians is of utmost importance to the Opticians Association of Canada.

In conclusion, we are truly honoured to be here to support the safety initiative that is definitely in the public interest. We stand as part of the eye health care community to support this.

Thank you very much for having us here today.

[The Chair, Conservative, Joy Smith]

Thank you very much.

We'll now go to our first round of questions. I want to thank the witnesses for very insightful information on this very important topic.

We'll go first to Dr. Morin.

[Dany Morin, NDP, Chicoutimi—Le Fjord, QC]

Thank you, Madam Chair.

Thank you so much to all the witnesses for their presentations. They were very insightful.

Thank you so much, Patricia. It was a pleasure for me to work on your bill while in an official position and to speak on it at second reading.

My first question is for Don Boyer.

I'd like your opinion on the amendments to Bill C-313, which we're studying today. Bill C-313 states that "a … cosmetic contact lens is deemed to be a Class II medical device". That's what Mrs. Davidson proposed. But there is an amendment that reads that "a non-corrective contact lens is deemed to be a device."

Are you in favour of that amendment, which would remove the reference to the class II medical device?

[The Chair, Conservative, Joy Smith]

Ms. Davidson, do you want to answer that, or should we give it to Mr. Boyer?

[Patricia Davidson, Conservative, Sarnia—Lambton, ON]

Ask Mr. Boyer.

[Don Boyer]

I'll be quite clear from the start. In my presentation, and from what we've heard today, the intention, as we understand the proposed bill, is that these will be class II medical devices.

The current wording of the proposed amendment deems a non-corrective contact lens to be a class II medical device. Unfortunately, that wording will likely not suffice in protecting consumers, because the definition of a device resides in the Food and Drugs Act. The proposed wording right now speaks to amending the medical devices regulations by deeming a lens a class II medical device.

Before we go there, because a non-corrective contact lens has no therapeutic purpose it does not meet the definition of a device in the Food and Drugs Act. So the bill would have to be changed to deem, within the Food and Drugs Act, that a non-corrective contact lens outside of the definition of device is deemed to be a device. Once that occurs, the regulations will apply.

[Dany Morin, NDP, Chicoutimi—Le Fjord, QC]

Thank you very much.

My next question is for all the witnesses.

You've all read Bill C-313. Are there any amendments you'd like to see? Is there anything that we could improve on in this bill?

[The Chair, Conservative, Joy Smith]

I'm sorry, the translation is not coming through.

[Dany Morin, NDP, Chicoutimi—Le Fjord, QC]

I can ask my question in English.

[The Chair, Conservative, Joy Smith]

Okay. Go ahead.

[Dany Morin, NDP, Chicoutimi—Le Fjord, QC]

My question is to all the witnesses. You have all read the bill. Are there any amendments we can make to improve it, or is it perfect as it is?

[Dana Cooper]

Thank you for the question.

My only comment is on timing. The sooner this gets passed the better. We will be ahead of the game in getting this regulation moving forward. We can then go to the provincial level and use it as a springboard to say, “Hey, it's federally regulated now, the same as corrective lenses. Now it's your turn to install the same changes.” It's all about timing. The bill would be better if it came into force on assent. That's about it.