HESA Committee Meeting
Notices of Meeting include information about the subject matter to be examined by the committee and date, time and place of the meeting, as well as a list of any witnesses scheduled to appear. The Evidence is the edited and revised transcript of what is said before a committee. The Minutes of Proceedings are the official record of the business conducted by the committee at a sitting.
For an advanced search, use Publication Search tool.
If you have any questions or comments regarding the accessibility of this publication, please contact us at accessible@parl.gc.ca.
Standing Committee on Health
|
l |
|
l |
|
EVIDENCE
Tuesday, February 14, 2012
[Recorded by Electronic Apparatus]
[English]
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?
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.
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.
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.
Thank you for your very insightful presentation, Mr. Cooper.
We'll now go to Ms. Jennifer Brunet-Colvey.
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.
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.
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?
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.
Thank you very much, Doctor.
We'll now go to Mr. Lorne Kashin from the 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.
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.
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.
[Translation]
Thank you, Madam Chair.
[English]
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.
[Translation]
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?
[English]
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.
Thank you very much.
[Translation]
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?
[English]
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?
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.
Thank you very much for your question.
I just want to point out that I worked very closely with the eye care professionals as we developed this. Hopefully we have within the bill itself what is needed for the protection of eye health. I also worked very closely with Health Canada. There may be a couple of amendments that are needed just to tweak some of the issues that Health Canada needs to deal with as this progresses through.
Hopefully the meat of the bill is correct and has in it everything that is needed to protect the eye health of Canadians.
Thank you.
Do I have more time?
[Translation]
If that's the case, I'll give Ms. Quach the remaining minute.
It's my turn to thank you for being here.
At the same time as all this, have you planned a preventive ad campaign aimed directly at young people who appear to see this product as a toy or as something harmless?
The question is for all the eye care professionals. Perhaps you have something planned?
[English]
I'm not planning on launching any campaigns, but I'm quite sure that the eye care industry would be willing to speak to that.
Actually, that would be phase two. Obviously moving forward, this is like a journey; this is the first phase, where we need to have your support in pushing this forward, and the next is education. Education is extremely important, but we would need this to go through all the proper channels and pass in order to have that ammunition to then go forward and launch, absolutely, a marketing campaign.
Thank you very much.
In regard to some of the things we are currently doing or have been doing, we're working with the Canadian Pharmacists Association to try to draft up a statement. We've been in contact with individual pharmacy chains in regard to just informing them about the risks of harm with regard to cosmetic contact lenses, and we regularly get reports of retailers retailing the products, with whom we can communicate.
There is an education perspective there, not aimed directly at teens but more at the retailers. When Bill C-313 receives assent, we want to work with Health Canada on public education notices. We want to work with the provinces on getting a regulatory environment in line there and then get their assistance also with the public education component of that.
Thank you very much, Madam Chair. I must say how pleased I am to see Pat Davidson back here at the table. I had the honour of serving with her for a number of years.
It's good to see you back, Pat. Thank you very much for this bill.
I did want to continue with the line of questioning my colleague, Dr. Morin, was moving towards. Dr. Cooper brought up a very important point about timing, and I think all of us around the table here would like to see this enacted as quickly as possible.
I was wondering, Mr. Boyer, if you would comment. We are proposing an amendment, and one of the concerns was its coming into force so that there is no confusion, so that it can move ahead without causing any distress. We do have an amendment that is going to read:
This Act comes into force on a day to be fixed by order of the Governor in Council.
I was wondering if you can comment on why that might be a good idea.
Certainly. Thank you very much.
There are two reasons for that amendment. The first reason is that this is the historical or traditional way of bringing this type of change into effect with a bill or a law.
Second, what's being proposed here is that the coming into force of the act be aligned with the coming into force of changed regulations. As I mentioned in my presentation, non-corrective contact lenses do not have any effectiveness with respect to correction of vision. Currently, the medical devices regulations require manufacturers to submit evidence of effectiveness. So bringing the bill into effect before the regulations can be amended would therefore make all non-corrective contact lenses unable to comply with the medical devices regulations, and I don't think that's the policy intent here of putting forward the bill.
We would still maintain, under the medical devices regulations, stringent requirements for safety, for the quality, and for the auditing of manufacturing facilities that produce these types of products, but the proposed revision and the wording would better align and synchronize the coming into force of the act with the coming into force of regulations that would exempt non-corrective lenses from the effectiveness requirements.
Thank you.
I wanted to talk about why cosmetic contact lenses are not regulated in Canada. Perhaps you could comment on the word “cosmetic”, and whether it causes confusion.
Let me address the “cosmetic” issue first. “Cosmetic” is currently defined in the Food and Drugs Act, and we are supportive of a revised definition in order to remove any confusion about the products addressed in this bill. These are known as non-corrective or plano lenses, and we believe that adding the word “cosmetic” to that definition will create confusion. There is already a separate definition that appears in the Food and Drugs Act and a separate regulatory framework that deals with cosmetics. So that's the first issue.
With respect to not being regulated, this is not the case. Non-corrective contact lenses have been regulated. What the bill is proposing is to put them in with products such as corrective contact lenses. Because they are likely made by the same manufacturers of similar materials, it was thought that they should be put with the medical devices regulations under the Food and Drugs Act.
Until this time, non-corrective contact lenses have been regulated under the authority of the Hazardous Products Act and the hazardous products regulations. More recently, they were considered under the Canadian Consumer Product Safety Act, which is where they sit right now. So it's not the case that they are not subject to regulation.
I think the proposed legislation would move these products into a regulatory framework that's more encompassing, that has pre-market requirements and post-market requirements, and that has quality requirements for the manufacturers.
Well, it makes sense, and other countries have done this in the interests of safety. I have a 10-year-old, and, yes, she does run the house.
Pat, I was wondering if you could comment on why this issue is important to you and what got you to put this bill together.
I started hearing about it when I was a member of this committee, meeting with some of the eye care professionals at my office. It was a subject that I had a great interest in. I've always had fairly poor vision and I've always tried to look after my eyes. It makes me cringe when I think of people who are not looking after their eyes. I look around this table and I see there are a lot of people in the same situation I'm in. I see a lot of corrective eyewear around this table. So I think you can understand where I'm coming from.
When you are young and have no vision problems, you see yourself as invincible. We need to do what we can to protect our young people. I have grandchildren coming up, too. I certainly don't want to see anything happen to their eyes. Something I've lived with all my life is poor eyesight, and good eyesight is something I value very highly. When the last thing you do at night is take your glasses off and the first thing you do in the morning is put them on, you realize what it's like not to be able to see too well.
So it was something that I had a great interest in, and I think it will especially help the young people in our society.
Thank you very much, Pat, and I'll move my glasses down to my nose to give that wise look.
Voices: Oh, oh!
Mr. Colin Carrie: Thank you.
Thank you, Madam Chair.
I don't have any questions. I think all the witnesses were pretty clear. As Pat knows, I have supported her bill fully. I'm intrigued by the reasons for going to Governor in Council, and I think it makes sense.
All I really want to do, Pat, is say that it's an extraordinarily important bill. As you said yourself, it's going to help young people.
I agree with Ms. Schmidt that the important thing is for us to have public education accompanying this bill, so that people can understand it. We see the scientific evidence and understand the arguments, and we tend to think the young people do as well. As a physician for many years, I can tell you that young people still think that if you cross your fingers you won't get pregnant. Young people just don't see the future as being real. They're young and everything's going to happen for them—it's all going to be great. So I think it's really important, the education piece. It's a key part that I wanted to support.
Anyway, thanks, Pat.
Thank you very much, Madam Chair.
I do want to thank all of our witnesses for being here today. It has been very educational.
A special thank you to our colleague, Pat Davidson. I echo the comments of my colleague across the way. As many of our witnesses have noticed, you brought this issue to the attention of the House of Commons. I have to admit my ignorance regarding this issue, and actually my surprise to find out that these lenses are not regulated in a way that ensures safe use.
My question is going to go to anyone who would be willing to answer. I need to understand the history and how it has happened that these non-corrective cosmetic lenses are on the market without any kind of regulation that would ensure the safe use of them. This is to whoever would like to answer.
I will attempt to answer that question. As I mentioned, these have not been on the market without regulation, but I think we would all agree that bringing it into the medical devices framework will provide that pre-market assurance that products are safe and of sufficient quality before they go on the market.
I don't think Canada has been unique in this particular situation. It was mentioned in one of the presentations that it took a long time in the United States. In 2005 they deemed them to be medical devices, similar to what the policy intent of this legislation is. In many other countries they are not regulated as medical devices. They are not regulated in Australia or in Europe, for example. Mexico seems to be moving towards the regulation of these products. Also, China has made some announcements that likely in the near future they will be regulating these products. We may be a little bit behind where the U.S. and some other countries are, but I think this is a good move for what we are doing today in bringing them into a regulatory framework that will allow them to be regulated from a product concept to a post-market surveillance of the products on the market.
Thank you.
My second question would be around public education. I think I need you to clarify. If I heard correctly, organizations and the industry have been waiting for some sort of designation under the Food and Drugs Act in order to do public education. I'm wondering why, as soon as these non-corrective cosmetic lenses came on the market, the industry didn't respond quicker to start to educate the public, and especially our youth, around the unsafe use of them.
I'd like to respond. I can speak to Ontario, where we hold neighbourhood eye care fairs. At these fairs we educate the public. We usually bring in an ophthalmologist and a number of opticians who do a lot of pediatrics...in different realms of what we do. At that point, we were educating consumers about these lenses. We also stir things up a little bit by visiting the stores that do sell these lenses and talk to the proprietors and let them know the risks with these things. I myself have attended some stores. It's business. They say, “If I don't sell these lenses, they are just going to go across the street.” It's not just the lens purchase they are going to lose; it's the other party supplies they are going to lose.
We have been doing what we can, but we can't stop it. We have been educating. We have been going down that road already.
Further, in regard to some questions with regard to public education, I haven't mentioned that all three organizations at this table—the opticians, the ophthalmologists, and the optometrists—annually prepare press releases to try to warn the public, particularly at the peak time of the year, which is Halloween, the day the bill hit first reading in the House. Particularly around that time of year we see a lot of activity from all three organizations trying to educate the public about the risks associated with these products and how to properly go about the proper use and purchase.
I just want to add a little bit to that.
As legislators, we all know it is very difficult for other people to promote something that doesn't have regulation behind it to prove that theory. It puts people who are educating the public in a difficult position if the regulation is not there for them to do that, so it's vitally important that it be there.
Thank you. I appreciate that clarification and the opportunity you've had to talk about what you are doing.
I have one last question, and it will be for Mr. Cooper. How long has your organization been lobbying government to make this change?
It predates my time at the organization. I don't think it predates our executive director, Glenn Campbell, but we've been working with Health Canada. In 2000 it issued a public health warning about cosmetic contact lenses, so it goes back that far, and even beyond, with regard to trying to get the regulations and pushing for regulation of these products.
Thank you.
We'll now go into our five-minute round. That's five-minute questions and answers, so our time is a little tighter.
We'll begin with Ms. Davies.
Thank you very much, Chairperson.
First, thank you to Ms. Davidson for coming to the committee, and to the witnesses.
We've been very pleased to support the bill, and today we'll kind of go through it in detail, and the amendments.
I have two questions. If the bill goes through, presumably with the amendments, I wonder if you could describe really clearly what it means for consumers. How will it actually change what they do, or will it at all? Some of you talked about the importance of fitting and having that professional oversight. I'm not clear whether or not these amendments will actually have that effect, whether they will change anything consumers do in terms of how they are purchasing these products or how they are fitted or not.
The second question is in terms of education. Who will actually do that? Everybody has mentioned it. I don't mean sort of a passive education in terms of information on a website where you have to wait for people to go somewhere, like Health Canada or maybe one of the associations. Is there a sense that education would then be carried out in a more proactive way, and if so, who would do that? Is it Health Canada, is it your associations, or is it all of you together? To me, if it's not sort of out there, then probably there will be very little awareness, even though you might have some education.
Could any of you address those two points?
Good morning. Again, thank you for your time this morning.
Perhaps I could mention that we've been working very closely with the American Academy of Ophthalmology, which is a very large organization representing more than 25,000 eye physicians and surgeons in the United States. It has been very encouraging having this legislation passed in Canada.
I immediately brought in Robert Dalton, who is the executive director of the Opticians Association of Canada, as well as Dana Cooper and Glenn Campbell, to this process to show them all of the great materials and the public education materials they have in the States. It's a collaborative effort, and certainly they have PSAs, they have Twitter feeds.
Help me out here, Dana. They have other different kinds of opportunities where people could actually look at little videos where all of this information is there. They do a tremendous amount of work, but it is usually during the month of October, leading up to Halloween. That's when the big public education push happens. But certainly there is a model out there and some terrific work in terms of public education. So there is a model.
Maybe on the second question, I really want to know what it means for the consumer. Is it going to change the way kids can actually purchase one of these devices? What does that mean?
Certainly access will change, and that's what this bill is about. It's to place these lenses in the hands of people who can fit them and, if you will, prescribe them. But that doesn't change the Internet. It doesn't change what you as an individual can do with the Internet. It changes the legislation, but people can bypass legislation. People take risks. Certainly people who sell material, any kind of material, on the Internet understand the legality of doing so. I don't know how we can affect that. That's a huge challenge.
Nevertheless, it will stop vendors and purveyors of these materials or these lenses. It will prevent them because there is an associated risk of breaking the law, and that's what we want to do. But it won't help unless there's a good public relations piece to support the education piece, to support the change in which these lenses will be made available and the risks associated with wearing them.
I think it was Mr. Boyer who mentioned that there are pre-market and post-market.... Will those companies be captured that way in terms of the Internet? Although they may be able to bypass the fitting procedure and so on, they will be caught by that. Is that correct?
Yes. There is a pre-market authorization by which a manufacturer would have to apply to Health Canada to obtain a licence to be able to sell this product in Canada. Part of the review of that will include some of the indications that the manufacturer is putting on the product, which could include instructions for use and that kind of information, which could become available to Health Canada to review prior to authorizing the product to be on the market.
Thank you, Joy.
Thank you, Pat Davidson, for all your great work. Like Colin said, it's great to have you back at the health committee after your numerous years of being such an activist on health issues.
I have a question. It was mentioned that in 2005 the U.S. Food and Drug Administration successfully introduced amendments to regulate it as a medical device. What are other countries doing in this? What information do we have in terms of how Canada needs to act more quickly on this, as suggested by your bill? It's a question to you, Pat, or anyone else who could highlight that.
As Mr. Boyer has stated, we're certainly not at the head of the pack when it comes to passing regulations. We are ahead of some of the other countries.
Perhaps you could just reiterate what....
In terms of the countries that I'm aware of, or the regions of the globe that I'm aware of, the U.S. deemed these to be medical devices in 2005, and therefore the full aspect of their regulatory framework applied to them at that point in time. Mexico is close to bringing in requirements for non-corrective contact lenses, and recent information indicates that China is also looking at doing so within the next little while.
Europe does not regulate these products. Australia does not regulate these products. We weren't at the head of the class, but we're not at the bottom of the class either.
It seems like a terrific bill.
Janice is from Barrie, Ontario. I'm very happy to see a representative from Georgian College here. I'm pleased to see you in support of this excellent piece of legislation.
Is there anything additional that you want to add? I know your time has all been very strict, given the time allotments. Is there anything else you want to get out on this bill, on the record?
Only that I believe it's been a long time in coming, and I'm so excited to be a part of this. That's all I'd like to say at this point. I'm very excited.
As Hedy mentioned, I think a lot of the questions have generally been asked, but Pat, is there anything else you wanted to add on behalf of your bill?
I'd just add a little bit to the question I was asked about why this was important to me. I talked a little bit about my own eye health and how I have an interest in making sure young people look after their own eye care. But another thing that really spurred me on to this was the fact that people I knew had damage done to their eyes. Actually, some of my staff members had damage caused from wearing the lenses. So that certainly was a personal issue, too, that helped spur this interest on.
[Translation]
Thank you, Madam Chair.
I'd like to thank the witnesses for being here today to provide us with more information on these contact lenses, which serve more a cosmetic function than a corrective one.
I'd like to thank Mrs. Patricia Davidson. I know that she has previously sat on the Standing Committee on Health and that this issue is dear to her. I have nothing but support for her initiative. As I've already said in the House, I support her bill.
As a doctor, I'm well aware of the consequences that using these contact lenses can have. Even then, some corrective contact lenses caused problems, despite all the precautions we were able to take. I know that things have improved over time. I think that non-corrective contact lenses could really become a public health problem, given the generations that use them a lot now, as you mentioned.
The following question is of concern to me. We sounded the alarm on this matter a few years ago now. So how is that the government has done nothing so far and we're around this table today, discussing this problem, when the United States did so long before we did?
[English]
Thanks very much for the question, and thanks so much for your support. I certainly appreciate you speaking in favour of this bill in the House. It means a lot to get support from all parties, and particularly from those who are so knowledgeable about the health care system in general.
As I said in my remarks, this is an issue that Health Canada was prepared to act on in 2007 when I presented my private member's motion, which actually was going to do basically the same thing. It was going to be included in some legislation that hopefully would have been passed in the House, but because of the election in 2008, that legislation did not go forward. Rather than wait until the legislation was reintroduced, I decided that it would be more prudent for me to introduce this as a separate, private member's bill, and since my time was coming up on the roster, I was able to do that.
Health Canada definitely has, in the past, indicated a willingness to go forward with this, and it was just timing that actually prevented it.
Thank you, Dr. Sellah.
Mr. Tilson, there's time for a couple of questions. We're going to stop right at ten o'clock.
Go ahead, Mr. Tilson.
I think Mr. Boyer talked about regulations. I'm interested in the penalties. Who does that? What are the penalties and where are they? Are they in regulations?
If someone violates this act—if it's passed, and it sounds like it's going to pass—what are the penalties and where are they?
I can speak, although this is not my particular area of expertise with respect to compliance and enforcement. I'm more on the pre-market side, but I think I can address the question.
There are certain penalties that are contained within the medical devices regulations themselves. For example, if, after we have authorized the product through a licensing mechanism, we find out that the product is not safe or is causing problems and some action needs to occur, we do have the authority under the regulations to cancel or revoke the licence for the product so that no further sales can take place. All mandatory problems that occur with these products need to be reported to Health Canada.
I'm assuming you're talking about the most extreme cases where we have somebody who is blatantly disregarding the law or the regulations. There are provisions in the Food and Drugs Act for fines to be administered. It's usually the last step in a compliance and enforcement action. We typically start with education and progress from there.
Thank you so much, Mr. Boyer.
We want to get on with the business of clause-by-clause. The bells are not the bells. It's just the beginning of session, so members can relax on that front.
I would ask that the witnesses just step back from the table, with our thanks for your presentation, and we will go into clause-by-clause.
Committee, we now have clause-by-clause, and I would ask that people be seated. If you want to carry on conversations, feel free to go right outside the door to do that. That would be great. Otherwise, you can be seated and listen to the clause-by-clause.
Thank you.
Okay, we're going to begin. We have, first of all, amendment G-1. Dr. Carrie, would you like to speak to that?
(On clause 1)
Thank you very much, Madam Chair.
First of all, I want to thank Mrs. Davidson and all the witnesses for being here and also my colleagues on the health committee for the support for this bill. I think everyone's in agreement that we'd like this bill to move forward.
We heard from Mr. Boyer about the necessity of tweaking it a little bit. The first amendment, as he stated, would replace lines 6 to 10 on page 1 with the following:
For the purposes of this Act, a non-corrective contact lens is deemed to be a device.
Is there any discussion?
(Amendment agreed to)
(Clause 1 as amended agreed to)
(On clause 2—Coming into force)
The Chair: Amendment G-2. Go ahead, Dr. Carrie.
Again, as we heard during the testimony, what we are suggesting, to avoid any confusion, is that Bill C-313 in clause 2 be amended by replacing lines 11 to 15 on page 1 with the following:
This Act comes into force on a day to be fixed by order of the Governor in Council.
[Translation]
I don't necessarily understand the details, but I would like to know if it needs to be done as soon as possible, once the Governor in Council makes his decision.
[English]
This convention is just the way Parliament works. But thank you for the question, Dr. Morin.
(Amendment agreed to)
(Clause 2 as amended agreed to)
The Chair: Now we are on amendment G-3. Dr. Carrie.
Thank you very much.
We are suggesting that Bill C-313 be amended by replacing the long title on page 1 with the following:
An Act to amend the Food and Drugs Act (non-corrective contact lenses)
Basically, to avoid confusion, it removes the word “cosmetic”, because it's already defined in the act in another way.
Thank you, Dr. Carrie.
(Amendment agreed to)
The Chair: Shall the title as amended carry?
Some hon. members: Agreed.
The Chair: Shall the bill as amended carry?
Some hon. members: Agreed.
The Chair: Shall the chair report the bill as amended to the House?
Some hon. members: Agreed.
The Chair: Shall the committee order a reprint of the bill as amended for the use of the House at report stage?
Some hon. members: Agreed.
The Chair: Congratulations. I think this is the only time this year we have actually been done before the end of committee. I want to congratulate you. And congratulations, Mrs. Davidson.
Some hon. members: Hear, hear!
The Chair: The meeting is adjourned.
Publication Explorer
Publication Explorer