Bill C-313 (Historical)

An Act to amend the Food and Drugs Act (non-corrective contact lenses)

This enactment amends the Food and Drugs Act to deem that a non-corrective contact lens is a device for the purposes of the Act. This enactment will ensure that non-corrective contact lenses are subject to the requirements of the Food and Drugs Act.

[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?

[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.

[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.

[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.

[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.

[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]

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?

Food and Drugs Act

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

Madam Speaker, I would like to take this opportunity to thank all parliamentarians who spoke in the House of Commons for their support of Bill C-313. I believe this legislation would strengthen consumer protection measures for Canadians and would serve to address the concerns raised with me by Canadian eye care professionals.

I also thank the House of Commons private members' business office and also legal services for their excellent work leading up to the introduction of Bill C-313. All of their work behind the scenes for MPs' legislative business is greatly appreciated.

In addition to my parliamentary colleagues, I thank the many professionals within the eye care community who have supported my private member's bill. In fact, members of the eye care community have been calling for the regulatory changes contained in my PMB for over a decade now. Bill C-313 has gained the support of three prominent national eye care organizations. The Canadian Association of Optometrists, the Opticians Association of Canada and the Canadian Ophthalmological Society are important stakeholders in any discussion on eye care.

Furthermore, my office has been contacted by numerous provincial bodies and even eye care organizations from across the United States and Europe, each of whom are extremely supportive of the work we are doing here today with regard to helping to make Bill C-313 law.

I believe the work of these professional eye care stakeholders in Bill C-313 would finally address the lack of regulatory oversight on what are called “non-corrective cosmetic contact lenses”.

Due to the importance of Bill C-313 toward consumer protection and the overall health and well-being of Canadians, I was able to obtain the full support of all the opposition parties and their health critics when my bill was first introduced. Today I thank them for that same support to send my bill to committee for further study.

I am also honoured to have the support of the Minister of Health and I thank her for her support on the bill.

Asked by constituents and others why I would bring Bill C-313 forward, I have explained that my objective was to fully address the concerns held by myself, other parliamentarians and thousands of eye care professionals across Canada about the impact that cosmetic contact lenses was having on the health of our youth and those unaware of the potential side effects of using such a consumer product.

For example, in the past few months, since Bill C-313 was introduced in the House, millions of cosmetic contact lenses have been recalled across North America. These lenses were sold by various companies over the Internet with little to no regard for the safety of the customer purchasing these products, which is exactly what this legislation intends to prevent.

Severe complications did occur for some of the consumers who purchased these tainted lenses, which led to the recent recall in question. Such complications are likely to occur due to unsafe handling and wearing an improperly fitted lens in one's eye. These issues are also known to increase with the lack of professional oversight when these products are initially obtained by the consumer. A list of complications would include the following: conjunctivitis, corneal abrasions, giant papillary conjunctivitis, microbial keratitis and other forms of bacterial, allergic and microbial infections as specified by the eye care industry.

Already we know that these complications all occur with prescribed corrective lenses, which is exactly why Health Canada regulates the use of those products through opticians and regulatory bodies.

Before I finish, I will share with members a quote from Dr. Lillian Linton, president of the Canadian Association of Optometrists. After Bill C-313 was introduced, she stated:

This is about people’s eyesight…. There are daily news stories from around the world about the complications that can arise due to ill-fitting cosmetic lenses or improper use and handling. It is an important vision health issue and the optometrists, opticians and ophthalmologists of Canada are asking for unanimous support from the House, Senate and Health Canada to adopt this amendment and enact it with haste.

The time has come for us as parliamentarians to join together to support Bill C-313 so we can ensure that the required regulatory changes are made. In doing so, we, as MPs, can ensure that the eye health of thousands of Canadians remains adequately protected.

With this in mind, I call on all parliamentarians in the House today to stand in support of Bill C-313.

[Jacques Gourde, Conservative, Parliamentary Secretary to the Minister of Public Works and Government Services]

Mr. Speaker, I am pleased to speak today to Bill C-313. This bill would have non-corrective cosmetic contact lenses covered by the same regulations as medical devices, under the Food and Drug Act and the Medical Devices Regulations.

Cosmetic contact lenses are also known as theatrical, decorative or non-corrective contact lenses. These products are sold in a wide range of colours and styles and are easy to purchase. Consumers can buy them in stores and on the Internet. Research reports show that the use of these products is growing, especially among adolescents and young adults.

There is every indication that the use of cosmetic lenses will increase and that they will be worn for all types of occasions. These contact lenses are called cosmetic because they do not correct vision. They change the colour or the appearance of eyes purely for aesthetic reasons.

You may be asking why we are considering such a frivolous item as a costume or fashion accessory. In response, I will say that they are not just costume or fashion accessories. As the sponsor of the bill, the member for Sarnia—Lambton, has said, this is about people's eyesight.

Users of cosmetic contact lenses place them directly on the cornea. I am convinced that you will agree with me that placing a contact lens directly on the cornea poses health risks, even though the product is especially designed and manufactured for the eye.

The consumer who buys this product over the counter is not always aware of the risks. We are interested in introducing simple and practical measures to mitigate this very real risk to health.

There are real differences between cosmetic and corrective contact lenses. Corrective contact lenses improve eyesight; cosmetic contact lenses only change the appearance of the eye. In Canada, the authority to determine whether a medical device is distributed by prescription rests with the provinces and the territories. At present, Canadian consumers who want to purchase corrective contact lenses must have a prescription.

However, non-corrective contact lenses can be purchased without a prescription in retail outlets, such as costume shops, or on the Internet. In fact, cosmetic lenses and corrective lenses are similar in many respects. Both are made with the same materials using similar production methods. Both are applied directly to the eye and both pose health and safety risks to those who wear them.

Some of the health and safety risks associated with wearing contact lenses include lacrimation, tingling and dry eyes. In extreme cases, these problems can lead to blindness.

For a number of years now, we have heard warnings about wearing contact lenses. As far back as 2000, Health Canada warned the public of the potential risks associated with wearing cosmetic contact lenses and recommended that these products be used only under the supervision of an eye care professional.

In addition to the information published by Health Canada, there have been many public communications regarding cosmetic contact lenses. Many Canadian associations for eye care professionals provide consumers with information on the risks associated with wearing cosmetic and corrective contact lenses and how to prevent these problems.

These professional associations adopted the position that the potential risks associated with wearing cosmetic contact lenses are equal to or greater than those associated with wearing corrective contact lenses.

The United States Food and Drug Administration also issued consumer warnings about the risks associated with wearing cosmetic contact lenses.

In 2008, our government introduced Bill C-51, An Act to amend the Food and Drugs Act and to make consequential amendments to other Acts, under which all contact lenses would be regulated as medical devices. However, Bill C-51 died on the order paper when Parliament was dissolved and the election was called.

Cosmetic contact lenses are currently not classified as a medical device since they do not provide any therapeutic benefits. That means that cosmetic contact lenses fall under the general prohibitions of the Canada Consumer Product Safety Act, which was passed in this House and came into effect in 2011.

This act is a solid piece of legislation that requires suppliers of consumer goods to report any safety-related incidents, recalls or other regulatory action in other jurisdictions.

The Canada Consumer Product Safety Act gives the government broad powers to take corrective measures, such as recalls and product corrections. It therefore authorizes the government to adopt corrective measures in all cases where a consumer product presents an unreasonable danger to people’s health and safety. Under this legislation, products must be assessed one by one in order to determine whether they represent an unreasonable danger, but only once they have been put on the market.

I would now like to reassure Canadian consumers that the Canada Consumer Product Safety Act provides greater protection than before when it comes to cosmetic contact lenses. As medical devices, cosmetic contact lenses fall under the Food and Drugs Act and the medical devices regulations. Companies would be obligated to ensure that their cosmetic contact lenses meet safety and quality requirements in order to be able to sell their products in Canada.

Health Canada may also request additional information regarding safety and quality before or after a decision concerning their sale in Canada. Therefore, as medical devices, cosmetic contact lenses would be subject to the same labelling requirements and consumer information standards as corrective contact lenses, before they are put on the market.

Moreover, the medical devices regulations contain permit issuance and inspection requirements to which importers and distributors are subject, in addition to a mandatory declaration by companies concerning any serious incidents that may have occurred. Many contact lenses are sold directly to consumers over the Internet and are subject to minimal or no safety and quality oversight measures. It is not mandatory to consult an eye care professional.

Bill C-313 does not address any obligation to obtain a prescription in order to purchase cosmetic contact lenses, nor any obligation on the part of consumers to consult an eye care professional to obtain a prescription. The regulatory authority of the medical devices regulations does not address these concerns. The onus would be on the provinces and territories to make decisions and implement measures, since the authority to set regulations forcing consumers to obtain a prescription to purchase this kind of contact lens falls under provincial jurisdiction.

I am, however, firmly convinced that Bill C-313 is better for Canadians because it will mandate greater oversight over the safety and quality of these products than is currently the case both before and after they are put on the market.

As a regulatory body, Health Canada will continue to provide health care professionals and the public with product safety information, and will continue to promote industry compliance with rules and regulations. Industry will be obliged to meet the requirements of the Medical Devices Regulations. A large number of companies that sell contact lenses in Canada also sell them in the United States where all contact lenses, whether corrective or cosmetic, have been regulated as medical devices since 2005.

It is our government's priority to harmonize these regulations with those of its foreign counterparts and to promote Canada-American co-operation in the regulatory sphere. Bill C-313 is an important step in this process. Support for Bill C-313 will also enable our government to meet its commitment to ensure Canadians' safety. This bill gives us the opportunity to address an important health risk. It comes in response to the concerns expressed by health care professionals.

In closing, Bill C-313 will make two similar products with comparable risks subject to a single regulatory mechanism.

[Lois Brown, Conservative, Parliamentary Secretary to the Minister of International Cooperation]

Madam Speaker, I would like to take this opportunity to commend and express appreciation to the member for tabling this bill and drawing attention to this important issue.

The member has been advocating for this issue since 2008, first by tabling a private member's motion and now with the introduction of this private member's bill. Bill C-313 proposes an amendment to the Food and Drugs Act, which would see cosmetic contact lenses classified and regulated as medical devices.

In Canada the authority to determine whether a medical device is subject to dispensing by prescription rests with the provinces and territories. Currently Canadian consumers wishing to purchase corrective contact lenses require a prescription, however, non-corrective contact lenses can be purchases without a prescription at retail establishments such as costume and party stores or over the Internet.

Cosmetic contact lenses are coloured lenses that, like corrective contact lenses, are inserted directly into the eye. However, unlike corrective lenses, cosmetic contact lenses are used only to change the normal appearance of the eye. They are not used to correct vision.

These lenses, which are sometimes referred as theatrical contact lenses, are often worn by actors in movies or TV shows. For example, in July 2010, CTV reported that Lady Gaga used cosmetic contacts to enlarge her eyes during the filming of her video Bad Romance.

Members will be interested to learn that the same news report cites Dr. Desmond Fonn of the Centre for Contact Lens Research at the University of Waterloo, saying that he finds it worrying that the lenses are so very cheap:

We don't know what these lenses are made of. We assume they're regular soft contact lenses, but because of the way in which they're sold, they must be made less expensively to make them marketable.

CTV reported that the doctor's biggest concern was that “the majority of the young kids who use these lenses buy them but have no education about them”.

Today, on special occasions like Halloween, many young people wear dramatic cosmetic contact lenses to go with their costumes. What many Canadian consumers may not be aware of are the risks associated with wearing these lenses.

Wearing cosmetic contact lenses can pose all of the same risks as wearing corrective contact lenses. This can include eye irritation, itching and burning, sensitivity to light, dryness, blurry vision and infections. In the most serious cases, these infections can lead to blindness.

In the case of cosmetic contact lenses, these risks are escalated due to the fact that there is no labelling requirement to warn consumers about potential risks and safety issues associated with wearing cosmetic contact lenses. There is also no requirement to include information or instructions relating to the proper use and care of these lenses. This means that after buying cosmetic contact lenses in stores or on the Internet, a consumer may not be well-informed about the potential risks and how to use and care for these products safely.

Unlike cosmetic contact lenses, corrective contact lenses are medical devices under the Food and Drugs Act and must comply with the medical devices regulations.

Cosmetic contact lenses are not considered medical devices because they are only used to alter appearance. As a result, they are not subject to the same level of regulatory oversight for safety and quality. Bill C-313 would help us address this discrepancy.

In the U.S. cosmetic contact lenses have been regulated as medical devices since 2005. Bill C-313 would enable us to align our regulatory approach on these products with our neighbours south of the border. It would also contribute to Canada's commitment to regulatory co-operation to better align the regulatory approaches on both sides of the border.

The use of cosmetic contact lenses is not a new issue. Eye care professionals have been concerned for a long time about the health risks of cosmetic contact lenses. They have called on our government to increase regulatory oversight of these products. In fact, on October 5, 2011, the Canadian Association of Optometrists, the Opticians Association of Canada and the Canadian Ophthalmological Society issued a joint press release welcoming the introduction of this bill.

That press release quoted Dr. Lillian Linton, president of the Canadian Association of Optometrists, as stating the following about the regulation of cosmetic contact lenses:

[It is] an important vision health issue and the optometrists, opticians and ophthalmologists of Canada are asking for unanimous support from the House, Senate and Health Canada to adopt this amendment and enact it with haste.

Health Canada has long acknowledged the risks associated with the use of cosmetic contact lenses. Over the past decade, Health Canada has communicated the risks of cosmetic contact lenses and has provided safety information for contact lens wearers. In 2000, Health Canada issued a public notice warning of the dangers of wearing cosmetic contact lenses.

Health Canada has in the past and continues to recommend that cosmetic lenses be used only under the supervision of an eye care professional. In addition, the wear time should be limited to the shortest duration possible. Cosmetic contact lenses must never be worn while asleep and should not be shared with others.

Our government's support for this private member's bill is not our first attempt to strengthen oversight. In 2008, there were two opportunities to enhance the safety and quality of cosmetic contact lenses. First, this House supported a motion by the member for Sarnia—Lambton calling for cosmetic contact lenses to be regulated as medical devices. Later that same year, this government tabled Bill C-51, An Act to amend the Food and Drugs Act, which would have resulted in cosmetic contact lenses being defined as medical devices. When the election was called, Bill C-51 died on the order paper.

This government moved to help protect the health and safety of Canadians with modernized consumer product legislation through the Canada Consumer Products Safety Act, which came into force in June of this year. While the act may provide protection for Canadians who use cosmetic contact lenses, we feel that cosmetic contact lenses would be more appropriately regulated as medical devices under the Food and Drugs Act. It would be clearer for consumers and industry alike.

With the exception of the respective functions of corrective and cosmetic contact lenses, the two products are essentially identical. They have similar manufacturing processes, they are used in the same manner and they pose the same health risks. When put this way, it only makes sense that both products be subject to the same level of regulatory oversight for safety and quality.

If cosmetic contact lenses were regulated by medical devices regulations, manufacturers would be required to attest to the safety and quality of their products before they were sold in Canada. Cosmetic contact lenses would also be subject to the same labelling, consumer instruction, licensing and inspection requirements as corrective contact lenses.

Bill C-313 would permit the pre-market safety and quality requirements for medical devices to be applied to cosmetic contact lenses. This would mean that Canadians would have access to clear consumer information about the risks associated with wearing cosmetic contact lenses and the proper and safe use and care of the product.

I will conclude by saying that Bill C-313 would allow for a consistent regulatory approach for similar products with comparable risks.

It is clear to Canadians that the risks associated with wearing cosmetic contact lenses are no lower than the risks associated with wearing corrective lenses and that it is important to be familiar with and follow the directions for using and maintaining both products. One of the most important measures that consumers can take is to consult an eye care professional before wearing either corrective or cosmetic contact lenses.

The government is committed to protecting the health and safety of Canadians. We should support Bill C-313 to help us attain this goal.

[Geoff Regan, Liberal, Halifax West, NS]

Madam Speaker, I am pleased to rise and take part in this debate on Bill C-313. This bill would deem a non-corrective contact lens a medical device. That is important because we do have situations where people put contact lenses in their eyes to change their colour. They are not always a proper fit and can cause all kinds of problems, and I will talk about that.

The bill would ensure as well that cosmetic contact lenses are subject to the requirements of the Food and Drugs Act and the Medical Devices Regulations. It is important that this is the case. These are things going into people's eyes and the last thing we want to do is fool around with the health of our eyes.

I am familiar with contact lenses because I used to wear them. I had laser surgery some years ago and that has worked very well for my vision. Before that, I wore contact lenses to play hockey. I have very dry eyes and they were very uncomfortable to wear longer than that, but I found they were great for playing hockey. Some would say I probably still need glasses when I play hockey, or something like that.

[Libby Davies, NDP, Vancouver East, BC]

Madam Speaker, I am very pleased to speak to Bill C-313.

I would like to thank the member for Sarnia—Lambton for bringing forward the bill. We are in the second hour of debate Some of my colleagues already spoke to the bill in the first hour of debate and signified our support for this legislation and that certainly continues. I do not know that there is more information to add in the second hour of debate, but it is important that we have a second hour of debate.

I want to begin my remarks by speaking more generally about what the bill raises in an important sense.

The health care system in Canada is huge. We have many health care concerns, such as natural health products and the mainstream health system itself. There is no doubt that we live in an age where more and more cosmetic-type therapies, aids and assistance, whether they are in drugs or other forms, are available on the market. One only has to look at television or any form of mass media to see the incredible amount of advertising and promotion of all kinds of products. One the one hand we can say that is a good thing in that consumers have lots of choice in this country. On the other hand, as members of Parliament we hear stories from our constituents of things that have happened to people or complaints that have been made.

With that huge array of products and therapies on the market there also has to be a sense of responsibility. It speaks to the importance of why we are here, why we have government, and that is to look out for the public interest. Sometimes the marketplace does not do all it is hoped it would do. It does not necessarily assume the responsibility of safety and awareness. Although there are many instances where voluntary associations of businesses or sectors promote awareness and education, they sometimes do not go as far as they need to go.

This bill provides illumination and an example--I was going to say a lens; excuse the pun--of the enormous number of products that are available and that there is not necessarily the kind of consumer awareness, education and regulation that is needed to make sure that people are safe.

For that reason, it is an opportune time for the bill to come forward. It draws attention to the problems with cosmetic contact lenses and the fact that they are not regulated and that they have caused problems for people. Consumers may not be aware of the possible infections, irritations or allergies and other problems that these products can cause.

Bill C-313 would amend the Food and Drugs Act to classify cosmetic contact lenses as class II medical devices, which would bring them in line with what we normally see as regular contact corrective lenses. This first step would require all cosmetic lenses sold in Canada to be licensed through Health Canada. Distributors of the products would require a medical device establishment licence. People fret about bureaucracy, rules and regulations, but we have to strike that balance.

In years gone by, going back to October 2000, Health Canada actually issued warnings about coloured contact lenses. In 2003, Health Canada commissioned a third party risk assessment report, “Human Health Risk Assessment of Cosmetic Contact Lens”. There are some serious concerns. The report concluded that the available evidence suggests that 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. The risk assessment report recommended that cosmetic contact lenses be regulated by Health Canada, such as requiring prescriptions for their use and restricting their sale to regulated health professionals.

It is very important that this be followed up. One query which was raised by some of my NDP colleagues in the earlier part of the debate was that while we are happy that the member brought forward the bill as a private member's bill, one would have hoped, as a result of this work that goes back to 2000 and 2003, the government would have brought it forward itself. That did not happen, but it is good that it is now before us as a private member's bill.

We are in full support of the bill. We believe it is very important that the vision of Canadians be protected, that there be consumer awareness, that there be proper regulation and that there be a level of professionalism within the industry so that consumers have some measure of protection. That is the very least we should be doing.

I think the bill will pass at second reading. I look forward to it going to the health committee. I hope that we can look at the bill in more detail and that we will be able to hear some witnesses. Major organizations are supporting the bill and I am sure they will have some good recommendations for us to look at.

Again, I want to thank the member for bringing the bill forward.

I hope that we can deal with this issue. We will have taken just a little tiny step to ensure there is better safety for Canadians in terms of their vision and that we will have created a better awareness about this problem.

When people are out there in the marketplace and getting drawn in by the sometimes very persuasive advertising and marketing that goes on, there could be a counterbalance to that in terms of regulation, to ensure there are proper standards and licensing, but also in terms of making consumers and potential buyers aware of what it is they are purchasing, what are some of the risks and what needs to be done in terms of handling and using this particular product.

I will leave it at that. I look forward to the bill going to committee to be examined in greater detail, should it pass second reading.

The House resumed from October 31, 2011 consideration of the motion that Bill C-313, An Act to amend the Food and Drugs Act (non-corrective cosmetic contact lenses), be read the second time and referred to a committee.

[Bev Shipley, Conservative, Lambton—Kent—Middlesex, ON]

Mr. Speaker, I thank my colleague, the member for Sarnia—Lambton, whose constituency is next door to mine, for bringing forward her bill, Bill C-313. I also acknowledge that she and I have spent time working together in terms of being a mayor. I think she holds the title of a warden of a county, elected more times and for a longer period than anyone of whom I know.

Bill C-313 would amend the Food and Drugs Act. Much has been said this morning about the significance of the bill. It is clearly one that wants to see cosmetic contact lenses classified and regulated as medical devices. It appears that the cosmetic contact lenses and, in fact, the corrective lenses go through the same process in their development. It is actually the oversight of the regulatory concerns that go with it.

The member and I both wear glasses. We come with two sets of eyes. These products are mostly used by younger people. We need to ensure that what we do we do for the best health of Canadians. I know all of us in this place come forward today to ensure that we do what we can to protect the health of Canadians.

Today I hear support for the bill. I want to congratulate my colleague for bringing forward this important issue on the health of our eyes.

[Ruth Ellen Brosseau, NDP, Berthier—Maskinongé, QC]

Mr. Speaker, first, I would like to thank my colleague from Sarnia—Lambton for introducing this bill. I think it is very important.

We must protect Canadians' ocular health. This very simple measure will help reduce the number of eye injuries. Cosmetic contact lenses must be subject to the same regulations as corrective lenses because they present the same health risks. Bill C-313 will help fix a problem that health care professionals have been calling on the government to fix for years.

One of the primary responsibilities of the government should be to protect Canadians from potentially dangerous products. The bill would ensure that corrective contact lenses and cosmetic contact lenses are subject to the same government regulations, since their use presents the same health risks.

Over the past 10 years, health care professionals have warned Canadians about the risks and dangers associated with using unregulated cosmetic lenses. In 2000, Health Canada issued a warning about cosmetic contact lenses and recommended that they be used only under the supervision of an eye care professional. In 2003, Health Canada recommended that the federal government regulate the use of cosmetic contact lenses.

The risks associated with using cosmetic contact lenses without professional oversight have been extensively documented. Problems occur when the contacts are not fitted to the eye—like shoe size, eye size varies greatly from one person to another—when the contacts are of questionable quality, or when they come from a truly unknown supplier.

Problems often occur when consumers are not given the appropriate and necessary information and instructions on how to use the contacts safely, for example, how to put them in, how to take them out and how to clean them.

Cosmetic contact lenses can be quite funky and there are many different types—there are some that look like soccer balls, some that make the iris appear larger, and other sometimes very funny things. Many young people share these contacts but they definitely should not in order to avoid infection.

Cosmetic contact lenses are becoming increasingly popular and, since today is Halloween, they are being sold absolutely everywhere: in convenience stores, beauty salons, and so on.

According to a report published by Health Canada in 2003, the rate of serious injury among people using corrective contact lenses every day is approximately 1% and the overall rate of complication is about 10%. It is estimated that the rate of injury and complication—for example, infection, inflammation or ulceration—is much higher among cosmetic contact lens users.

In 2007, vision loss accounted for the Canadian health care system's highest direct cost, as compared to any other illness. Doctors also say that wearing these contacts prevents people from seeing contrasts properly. Contact lenses reduce the eyes' sensitivity. It is sometimes very difficult to see when wearing cosmetic contacts because there is something in the eye. This results in improper vision. Someone who is wearing them while driving could even cause an accident.

There are many viruses and bacteria that attack the eyes, and we never know which may attack our eyes. This can happen if we share lenses with a friend who has an infection. So we have to be very cautious when we share contact lenses with other people. The best thing is simply not to do it at all.

Wearing cosmetic contact lenses can lead to a lot of other problems.

These contact lenses are meant to be worn up to a certain date. There is an expiry date, as for milk. Often, people who wear them forget to take them out and throw them in the garbage. That leads to various complications, such as corneal ulcers. Corneal ulcers are genuinely dangerous and can cause scarring of the eyes. That is truly dangerous. If they are not treated, the ulcers can even lead to permanent loss of sight.

Even though cosmetic contact lenses seem harmless, they can cause eye injuries in a person who wears them: an allergic reaction, a bacterial infection, swelling or inflammation of the cornea, and ulceration or scratching of the cornea. These sight problems can become permanent.

Some of these injuries occur in less than 24 hours. They can be very difficult to treat and in some cases can become permanent. The potential risks associated with this type of contact lens are a known fact. As well, there are numerous studies and there is considerable evidence showing the potential dangers associated with misuse of cosmetic contact lenses without supervision by a specialist.

But passing this bill is merely the first step. What the federal government has to do is work with the provinces and territories to establish an effective regulatory scheme for cosmetic contact lenses.

We are talking a lot about Halloween. As mothers, we look for clothing to use for costumes. My little boy, who is 10 years old, has asked for contact lenses for his costume. I therefore think that regulation is very appropriate, and I congratulate my colleague opposite on her bill.

I join my colleagues in the NDP in supporting this bill.