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

This bill was last introduced in the 41st Parliament, 1st Session, which ended in September 2013.

Sponsor

Patricia Davidson  Conservative

Introduced as a private member’s bill.

Status

This bill has received Royal Assent and is now law.

Summary

This is from the published bill. The Library of Parliament often publishes better independent summaries.

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.

Elsewhere

All sorts of information on this bill is available at LEGISinfo, provided by the Library of Parliament. You can also read the full text of the bill.

Food and Drugs Act
Private Members' Business

May 31st, 2012 / 5:15 p.m.
See context

Liberal

Hedy Fry Vancouver Centre, BC

Mr. Speaker, I continue to support Bill C-313 from the member for Sarnia—Lambton. Bill C-313 has received support from all parties.

As we all know, the bill is aimed to classify non-corrective contact lenses according to subrule 2(1) of part 1 of schedule I of the Medical Devices Regulations, which states:

Subject to subrules (2) to (4), all invasive devices that penetrate the body through a body orifice or that come into contact with the surface of the eye are classified as Class II.

I also thank the hon. member for being very open to amendments and suggestions at the committee stage of the bill. In fact, there was an amendment that very much improved her bill, which was that it would be best to classify the non-corrective contact lenses as a device under the Food and Drugs Act as opposed to a medical device. The member agreed to that.

I want congratulate the member and her bill has the support of the Liberal Party because we believe in sound, evidence-based policy, and this bill would do exactly that. I thank the member for continuing to pursue this. I look forward to its passage.

I had hoped that it would have been in the budget but, alas, that was too much to hope for.

Food and Drugs Act
Private Members' Business

May 31st, 2012 / 5:15 p.m.
See context

NDP

Don Davies Vancouver Kingsway, BC

Mr. Speaker, it is a pleasure to rise in the House and not only speak to Bill C-313 but also to offer the support of the official opposition, the New Democratic Party, to the proposed legislation.

This enactment will amend the Food and Drugs Act to deem that a non-corrective cosmetic contact lens is a medical 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 and the medical devices regulations.

Corrective contact lenses are classified and regulated as medical devices under the Food and Drugs Act and are regulated as class II medical devices by Health Canada. Despite the fact that the health risks are identical to corrective lenses, cosmetic or non-corrective contact lenses are not classified as medical devices and are not regulated by Health Canada. In other words, under federal and provincial law, it currently is permissible to sell cosmetic lenses in any retail establishment without a prescription.

There is, however, an abundance of evidence and research concerning the potential dangers of using cosmetic contact lenses improperly and without professional involvement.

Bill C-313 would amend the Food and Drugs Act to classify cosmetic contact lenses as class II medical devices, the same category as regular corrective lenses. This is a first step that would require all cosmetic lenses sold in Canada to be licensed through Health Canada and for distributors of the products to require a medical device establishment licence.

The bill, however, would only be the start of regulations of cosmetic contact lenses. Prescribing and dispensing regulations are provincially controlled. The next step would be for the provinces to also change their regulations to treat cosmetic lenses the same as corrective lenses.

The hope is that the passage of this bill will bring the issue to the attention of provincial health ministers, and it is essential for governments to establish a firm timetable for achieving effective regulations of these devices.

By way of background, what are cosmetic contact lenses? These are lenses that are usually used to change the colour and/or appearance of eyes. They have become increasingly popular, being marketed as fashion or Halloween accessories, at beauty salons, novelty shops, flea markets, convenience stores and through online businesses.

While it is difficult to estimate the exact size of the cosmetic contact lens market in Canada, all available indicators point to a growing market in recent years. It is also mostly young people, who are often less informed and more prone to taking risks, who are wearing cosmetic contact lenses more frequently.

There is no essential difference between cosmetic contact lenses and corrective lenses because both are inserted in and interact with the eye. Moreover, some cosmetic lenses cover a larger portion of the eye, known as the sclera lens, and do not have the same oxygen permeability as corrective lenses and may be more dangerous.

Cosmetic lenses can be worn safely, just as is the case for corrective lenses, provided they are appropriately prescribed and dispensed by a licensed professional. However, problems arise when they are not suited for the particular purchaser or are an improper size and are not fitted correctly. Each eye has its own unique shape and curvature. Also, if they are of questionable quality from an unknown supplier, they can be dangerous.

It is often the case that critical information and proper instructions are not provided to consumers concerning how to use the lenses safety, for instance, concerning insertion, removal and cleaning. Again, it is mostly youth, who are more prone to taking risks, who are wearing these devises and risking damage to their eyes.

Although cosmetic lenses appear harmless, serious eye injuries can occur, as an allergic reaction, bacterial infection, swelling or inflammation of the cornea may result. In serious cases, ulceration or scratches of the cornea, impaired vision and even blindness or eye loss can be the result. Some of this damage can occur in as little as 24 hours, can be difficult to treat or there can be permanent damage caused. The risk of potential harm for any type of contact lenses has already been proven.

There is an abundance of evidence and research concerning the dangers of using cosmetic contact lenses improperly and without professional involvement. By way of international comparison, until 2005, the U.S. also exempted cosmetic contact lenses from regulation under its food and drugs act. At the urging of eye care professionals, of course, a bill was passed to ensure that all contact lenses, corrective or cosmetic, are regulated as medical devices within the United States.

Now, according to the FDA in the United States, it is against the law in the U.S. to sell cosmetic contact lenses without a valid prescription or note from an eye doctor.

In October 2000, Health Canada issued a health warning about cosmetic lenses because of their being obtainable without a prescription, being improperly fitted and not being subject to health assessment as corrective lenses. It highlighted the risks and potential for injury associated with cosmetic lenses and recommended that they only be used under the supervision of an eye care professional.

In September 2003, Health Canada commissioned a third party risk assessment, entitled “Human Health Risk Assessment of Cosmetic Contact Lens”. In it, it 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”.

Given these risks, it recommended that cosmetic contact lenses be regulated by Health Canada and that they require a prescription for their use and that their sale be restricted to regulated health professionals.

In March 2008 a motion passed unanimously in the House called for the development of a regulation that cosmetic contact lenses be regulated as medical devices under the FDA or the Hazardous Products Act. It received all-party support and was passed unanimously.

After the motion, the government incorporated the motion's recommendation into one of its omnibus health bills, Bill C-51, as it was known then. Unfortunately, that legislation died on the order paper when Parliament was prorogued.

The NDP believes that the vision health of Canadians should be protected and that this is a simple measure that would help reduce the incidence of eye injuries. As both types of lenses have the same set of health risks, the regulations for cosmetic contact lenses must be the same as those for corrective contact lenses.

This bill addresses an issue that optical health professionals have called on the government to fix for years. It has taken a Conservative member of Parliament, to her credit, independently suggesting regulations for cosmetic contact lenses to bring this issue to the government's attention. It is regrettable that it requires a private member's bill. This is something that should be implemented by the government immediately. The NDP recognizes that this is an important first step for the federal government to take to finally establish an effective regulatory regime for cosmetic contact lenses.

There is broad, unanimous and widespread support for this measure in the stakeholder community. The Canadian Association of Optometrists, the Canadian Ophthalmological Society and the Opticians Association of Canada all have been publicizing the risks associated with this product and asking Health Canada to regulate them under the Food and Drugs Act.

The Canadian Association of Optometrists, talking about people's eyesight and, in most cases, young people's eyesight, stated:

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.

There has been increasing activity in Europe, Asia and, as I said, North America by associations calling for exactly that.

According to key facts and figures, it has been estimated that the rate of injury and complications for this use is around 1% of all users. This is an alarming rate, considering the number of contact lenses in use. Recent studies in France and by the FDA in the United States make it clear that this is a potentially dangerous object that should be regulated.

Finally, these regulations are to protect Canadians' vision health, especially in young people, who may not appreciate the consequences and risks associated with cosmetic contact lenses.

One of the first responsibilities of government should be to protect Canadians from potentially dangerous products. This bill would ensure that corrective and cosmetic contact lenses would have the same protection from the same health risks and would be regulated in the same way by government. This bill is a simple measure that would help prevent eye injuries in Canada, and the New Democrats are proud to support this logical, reasonable measure that is long overdue.

Food and Drugs Act
Private Members' Business

May 31st, 2012 / 5:25 p.m.
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Conservative

Patricia Davidson Sarnia—Lambton, ON

Mr. Speaker, it is a pleasure to stand here this evening as we go through the final second hour of third reading of my private member's Bill C-313.

This has been a fairly long process. It started back in 2007 with the introduction of my private member's motion, which as the member across has alluded to, was passed unanimously but then died on the order paper. It is greatly gratifying to see that the bill has reached this stage.

I want to thank the members who have spoken not only tonight in favour of this bill but all the way through this process. Whether it was through second reading or whether it was at committee stage, there has been wonderful support for the bill. All members and all parties have shown support, and I thank them for that.

There has been support through two ministers of health, as well, and Health Canada. The bill has been very well supported.

The industry has been 100% supportive. I have received a great deal of assistance from it in getting the correct medical facts. I have received wonderful support from everybody involved.

We know that this bill would help improve and protect the eye health of Canadians, as has been said in many cases, affecting our young people more than others.

I am pleased to see the bill at this stage. I look forward to its being passed through the House and sent on to the other place.

Food and Drugs Act
Private Members' Business

April 4th, 2012 / 6:05 p.m.
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Conservative

Patricia Davidson Sarnia—Lambton, ON

moved that the bill be read the third time and passed.

Mr. Speaker, it is an honour to stand among my fellow parliamentarians today as I speak in support of my private member's legislation advancing to third reading.

Bill C-313, an act to amend the Food and Drugs Act (non-corrective contact lenses), has received unanimous all-party support at every level of debate since its introduction in the House. Even at the committee review stage, all parliamentarians from the various parties have expressed their full support.

In the few months since my legislation was first introduced, there have been millions of non-corrective contact lenses recalled across the North American marketplace for quality control issues. Such stories have become more common, and Canadians are just beginning to open their eyes to the importance of their eye health. As we shed more light on this issue, we will continue to hear about such product recalls in the news. That is why Bill C-313 is supported across party lines and by virtually all Canadian eye health professionals. Canadian policy-makers are keenly aware of the impact my legislation would have across Canada, just as many of my colleagues have followed my legislation's progress.

Organizations like the Canadian Association of Optometrists have been key players in helping to spread the word on this important consumer health issue. The Canadian Association of Optometrists, the Opticians Association of Canada and the Canadian Ophthalmological Society have all come out in support of this legislation, and many more provincial bodies and their representatives have voiced their support as well. I will share some of their opinions with the House in due course.

I would like to thank the individual optometrists and ophthalmologists who have taken time from their busy practices right across Canada to write to me to voice their support. I realize that many of these same professionals took the time to write to their own MPs, asking them to support this private member's business, and for this I am grateful.

As we discuss the bill now at third reading, I intend to share medical evidence with the House that will provide clear reasons why we need my legislation. However, before we discuss Bill C-313 further, I want to take members back to the autumn of 2007 in the 39th Parliament of Canada.

One of my first responsibilities as a new member of Parliament was to be a member of the Standing Committee on Health. Looking back at my time on that specific committee, I was particularly seized by the concerns that were brought to me by professional eye care organizations from across Canada about the lack of regulatory oversight of what were called cosmetic contact lenses.

It is easy to break down the main concern brought forward to me all those years ago. A cosmetic contact lens is identical to a corrective lens in its impact on the human eyeball, with the only difference being that it does not correct a sight imbalance. However, despite the fact they are identical to a corrective lens, these cosmetic lenses have been free of regulatory oversight similar to the provisions in place for corrective lenses. It was with this in mind that I began to work in 2007 to further understand the risks of cosmetic contact lenses.

After extensive study, liaising with health researchers and eye care professions and meeting with our own experts from Health Canada and engaging with the opposition health critics, I developed a strategy that would go further toward protecting the eye health of Canadians everywhere. The result was private member's Motion No. 409, which proposed that cosmetic lenses should be classified as medical devices and be regulated accordingly under the Food and Drugs Act. The actual text of Motion No. 409 read as follows:

That, in the opinion of the House, the Minister of Health should regulate non-corrective, cosmetic contact lenses as medical devices under the Hazardous Product Act or the Food and Drugs Act.

This motion passed unanimously on March 7, 2008, in a fractured minority Parliament no less, which I believe is testament to the fact we are discussing an important health matter that could impact many Canadians, especially our youth. When faced with the facts on non-corrective contact lenses in 2008, we as a Parliament did the right thing by supporting Motion No. 409 and we stand to do so again with Bill C-313.

I was pleased that the government acted upon the unanimously passed motion. It was 2008 when the Government of Canada, upon advice from Health Canada, introduced my motion as an amendment to former Bill C-51, an act to amend the Food and Drugs Act and to make consequential amendments to other acts. That act was introduced in April 2008 but also died on the order paper upon the election in the fall of 2008.

That was unfortunate. Having already used my private member's spot in the 39th Parliament, I found myself near the bottom of a long private members' business list. It can be a long wait before MPs have the opportunity to again bring forward legislative items once they have used their spot on that list.

Moving ahead to late 2010, in the 40th Parliament it became evident that I would be able to bring forward private members' business. Knowing that Canadians still had concerns about the existing policies in Canada surrounding non-corrective cosmetic lenses, I directed my research staff to determine what types of legislative remedies could be brought forward. In short order, they developed opinions to deal with my previously unfinished private members' business as a stand-alone piece of legislation.

More time passed. Subsequently, we had another election and I was re-elected by the good people of Sarnia—Lambton. With the return of the 41st Parliament, my name was near the top of the list for private members' business, meaning that months of research and efforts by my office were about to be realized and we would finally be able to bridge the regulatory gaps that exist for decorative non-corrective lenses.

This legislative process has taken place across three different sessions of Parliament and now stands at third reading before the House of Commons.

With this background on my bill before the House, I would like to speak directly to Bill C-313, An Act to amend the Food and Drugs Act (non-corrective contact lenses).

Eye health professionals have been saying for a long time what we now know to be fact: National distribution of these products without professional oversight, fitting and training significantly increases the risk of public harm. This is the main finding captured by independent research reports. It is what Canadian eye health organizations have found. Now we see peer-reviewed science from reputable academics and institutions across the globe now fully supporting these findings.

To speak to the potential medical issues than can arise from the use of non-corrective contact lenses, stating that a decorative lens is potentially a harmful product may seem to some to be an overstatement, yet medical researchers have shown otherwise.

A list of the complications that could occur due to unsafe handling and the wearing of an improperly fitted lens in one's eye includes the following: conjunctivitis; corneal abrasions; giant papillary conjunctivitis; microbial keratitis; and other forms of bacterial, allergic, and microbial infection, 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 these products through opticians and regulatory bodies. Furthermore, it has been proven through peer-reviewed studies that non-corrective lenses are much more likely to cause complications to users because of a combination of factors, including lack of oversight of the product for the consumer, in particular how to use the product and issues with the potential quality of the product.

The Internet market for these products has grown immensely, even since 2006. We are talking about a market share in the millions and tens of millions of dollars. Much of this revenue is taken offshore. We need to ensure that Canadian consumer are protected when it comes to such operations.

To date, we have now seen several studies on the issue of 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 of 2003 and outlined the scientific evidence, which at that point was still being debated by public health officials, namely that the level of risk associated with the use of cosmetic contact lenses is comparable to that associated with corrective lenses, and may potentially be higher. The main issue here is that corrective lenses are subject to professional monitoring and proper regulatory oversight. Cosmetic lenses are not.

The Dillon report also called for the following risk management strategies: individual screening should take place before a cosmetic lens is sold to a customer; proper fitting should be ensured; adequate instruction on cleaning and sterilization should occur; and consumers should be made familiar with potential symptoms related to the condition of the eye; and regular aftercare is needed.

To date, not one of the suggested risk management strategies called for in this report has been adopted, while corrective lenses are strictly defined by Health Canada. My legislation would address this problem.

Whereas the long list of issues associated with non-corrective contact lens use was once viewed somewhat contentiously by policy-makers, such health concerns are now considered an accepted fact of non-corrective contact lens use, due to a recent study that appeared in Acta Ophthalmologica, the official medical journal for optometrists and ophthalmologists in Europe. In this study, research conducted by the department of opthalmology at Strasbourg University Hospital in France clearly indicated the following:

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

The study in question focused on a bacterial infection known as microbial keratitis, a common yet preventable infection that can occur in wearers of contact lenses, both the corrective and non-corrective, cosmetic varieties. This study showed that wearers of cosmetic lenses were indeed at higher risk, with 79% of the control group of cosmetic contact lens wearers suffering from corneal scraping. However, the study showed that only 51% of the corrective contact lens wearers suffered similar effects. Meanwhile, more than half of the cosmetic lens wearers who were shown to have suffered corneal scraping were also shown to have serious microbial infection in the eye.

The study concluded that the increasingly documented risks of easily accessible cosmetic contact lenses were a serious concern in the country of France, where the study took place. In this regard, there is no reason to believe that the situation is any different in Canada, and 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.

Considering the medical evidence that clearly shows the need for the provisions contained in Bill C-313, it is important to note that Canada is at least a decade behind other jurisdictions, such as the United States and Europe, in achieving proper regulations for non-corrective cosmetic lenses.

In 2008, M-409 was able to obtain the full support of all opposition parties and their health critics, in addition to the support of the government and the Minister of Health.

Today, with Bill C-313, I ask hon. members to stand with me once again as we deal with this important issue. Listen to what some of our leading eye care experts from across Canada have had to say about this piece of legislation.

An optometrist from Newfoundland has stated, “In my province there are novelty shops and drugstores that are selling these lenses without regard for the possible health implications to eyesight. All our opticians want to stop this activity of unregulated dispensing”. Moreover, Clearlycontacts.ca, a Canadian ebusiness provider of vision-care products, has also stated on the record that, “At Clearlycontacts, we support regulatory oversight in the sale of non-corrective contact lenses and fully support Bill C-313”.

Dana Cooper of the Canadian Association of Optometrists has said that:

Bill C-313 is a commonsense 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.

In addition, I have also received strong endorsements from the Opticians of Manitoba, the Saskatchewan College of Opticians and also the School of Optometry and Vision Science in Waterloo, Ontario.

Internationally, Bill C-313 has the support of esteemed groups, such as the Contact Lens Institute of Florida and the American Optometric Association of Virginia.

The need for this legislation has never been greater than it is today. The Internet marketplace has opened doors for international buyers and sellers of these products like never before, and as policy-makers we have a duty to ensure that the eye health of Canadian consumers is protected as much as possible.

I believe that Bill C-313 is the first step in this direction, and today I call on all esteemed members of this House to stand in support of my private member's legislation.

Food and Drugs Act
Private Members' Business

April 4th, 2012 / 6:35 p.m.
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Liberal

Carolyn Bennett St. Paul's, ON

Madam Speaker, I am pleased to speak, literally, as the voice of the member for Vancouver Centre, who seems to be suffering from body betrayal today.

I would also like to thank the member for Sarnia—Lambton for introducing Bill C-313.

The fact that this bill has received support from all parties in the House this evening is a rare occurrence in this place. Miraculously, the bill was also allowed to be improved upon in committee, which is also a little bit rare in this place these days.

Initially, the bill aimed to classify non-corrective contact lenses according to subrule 2(1) of part 1 of schedule I of the Medical Devices Regulations, which states:

Subject to subrules (2) to (4), all invasive devices that penetrate the body through a body orifice or that come into contact with the surface of the eye are classified as Class II.

A class II medical device is a low risk device, including contact lenses, pregnancy tests, ultrasound scanners, endoscopes, et cetera. Manufacturers require a Health Canada licence before selling or advertising Class II devices. Annual licence renewals are required.

Health Canada noted in committee that because these non-corrective contact lenses have no therapeutic benefits nor aim to correct vision, it would be best to classify this as a device under the Food and Drugs Act as opposed to a medical device. 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. By making this change to a device, regulations under the FDA would apply and the committee, therefore, passed this amendment. By adding non-corrective contact lenses as a device under the Food and Drugs Act, we can ensure greater safety in the manufacturing and sales of these decorative contact lenses.

In November 2005, the United States declared all contact lenses, corrective and non-corrective, as medical devices requiring a prescription.

The United States food and drug administration states:

Without a valid prescription, fitting, supervision, or regular check-ups by a qualified eye care professional, decorative contact lenses, like all contact lenses, can cause a variety of serious injuries or conditions. For example, lens wear has been associated with corneal ulcer, which can lead rapidly to internal ocular infection if left untreated. Uncontrolled infection can cause corneal scarring, which can lead to vision impairment, and in extreme cases, blindness or the loss of an eye. Other risks include conjunctivitis; corneal edema (swelling); allergic reaction; abrasion from poor lens fit; reduction in visual acuity, contrast sensitivity, and other visual complications that can interfere with driving and other activities.

A motion calling for non-corrective contact lenses to be classified as a medical device was unanimously passed in the House of Commons, as the member has stated, in March 2008.

Non-corrective contact lenses designed to change the appearance or colour of one's eyes should be listed as a device in order to protect consumers. Placing a contact lens on the surface of the eye that does not fit properly or is poorly manufactured can lead to many health concerns as was identified by the U.S. FDA.

The Liberals support evidence-based policy and recognize that this measure has been advocated for in the U.S. by groups such as the American Academy of Ophthalmology, the American Optometric Association, the Contact Lens Association of Ophthalmologists, Prevent Blindness America and the Contact Lens Institute. It is also supported by the Canadian Association of Optometrists, which has called on parliamentarians to “enact it with haste”.

Bill C-313 was amended in committee to remove the word “cosmetic” as this is defined elsewhere in the Food and Drugs Act and should not be applied to a medical device. It was amended to remove “Class II medical device” because all class II devices have to show proof of effectiveness and non-corrective contact lenses are not meant to be effective.

It was further amended to provide for the coming into force on a date specified by the Governor in Council.

Bill C-313 was supported by all witnesses at the health committee and all members passed this bill.

We congratulate the member for Sarnia--Lambton for this important initiative. We, too, think it has taken a very long time and look forward to its passage in this place.

Food and Drugs Act
Private Members' Business

April 4th, 2012 / 6:40 p.m.
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NDP

Djaouida Sellah Saint-Bruno—Saint-Hubert, QC

Madam Speaker, this is not the first time I have had an opportunity to speak to this bill. I spoke at second reading and when it was referred to the Standing Committee on Health. As far as I know, every party in the House supports this bill.

Non-corrective contact lenses, as they are now known following amendments to the bill in committee, are used to change the eyes' colour or appearance. Over the past few years, the market for these contact lenses has grown considerably. There is no real difference between corrective lenses and cosmetic lenses in terms of how they interact with the eye.

Even though they present the same health risks, non-corrective contact lenses are not yet classified as devices under the Food and Drugs Act, nor are they regulated by Health Canada. There is plenty of evidence about the risks associated with using non-corrective contact lenses without professional supervision.

Problems occur when the contacts are not adapted to the specific needs of the buyer, when they are the wrong size and do not fit the eye properly, 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 information and instructions on how to use the contacts properly and safely, for example, how to put them in, how to take them out and how to clean them.

Health Canada has warned the public and the government of the potential risks associated with non-corrective contact lenses. According to a 2003 Health Canada report, 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 non-corrective contact lens users than among those who use corrective lenses. In 2007, vision loss accounted for the Canadian health care system's highest direct cost, as compared to any other illness.

What is more, 75% of the cases of vision loss can be prevented. Bill C-313 seeks to amend the Food and Drugs Act to deem a non-corrective contact lens to be a device. This amendment would require all non-corrective contact lenses sold in Canada to be licensed by Health Canada and would require the product distributors to have a medical instrument sales licence.

As I said at the previous reading, I am surprised and disappointed that we are still talking about such a bill in 2012. In 2000, Health Canada issued a warning about non-corrective 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 non-corrective contact lenses, but, 12 years later, the matter is still not resolved. Nevertheless, I want to express my appreciation to the hon. member for Sarnia—Lambton for her bill and her perseverance.

I know that she has been working on this particular file since at least 2008, when she moved a motion that was adopted by the House of Commons. However, we are currently discussing the budget, and I hope it will be discussed for some time, even though it may not be in this House.

Budget cuts will affect Canadian families. They are talking about the cuts and will continue to do so. When I see measures such as these, which are essential, I wonder if they will have any real impact given the 2012 budget.

Regulatory measures such as this bill cannot be effective without some oversight. When I see the budget cuts made by this government, including those to Health Canada, I doubt that the department will be able to do the necessary follow-up with the manufacturers.

How can we protect public health and safety with minimal and limited monitoring?

I know that the government will say that Canadians' safety will not be compromised. However, I am not absolutely convinced of that. I do not have to look too far to realize why. I only have to read the Auditor General's report on the F-35 jets and compare his comments with the statements made by this government's members in this House.

Speaking of the Auditor General, I would like to point out that, yesterday, he blamed this government for the Canada Border Services Agency's performance. He said, and I quote:

In the small percentage of cases where goods that did not meet import requirements were allowed to enter the country, most were products for which there was no agreement in place between Health Canada and the CBSA. While the CBSA has formal arrangements with the three other organizations in our audit, as yet it has no formal agreement with Health Canada that documents respective roles, responsibilities, policies, and procedures for implementing controls on several products under Health Canada’s responsibility, such as medical devices [including the one we are talking about today] and pest control products. Until there is a formal agreement, border services officers do not have consistent instructions on procedures to follow for those products.

Non-corrective contact lenses are often ordered via the Internet. I hope that this government takes the Auditor General's recommendations in this regard seriously and gives the Canada Border Services Agency and Health Canada the means to protect the health and safety of Canadians. If not, this bill will serve no useful purpose.

Food and Drugs Act
Private Members' Business

April 4th, 2012 / 6:50 p.m.
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NDP

Glenn Thibeault Sudbury, ON

Madam Speaker, I am very happy to stand here today in support of this private member's bill in the name of the member for Sarnia—Lambton. Bill C-313 would amend the Food and Drugs Act in regard to cosmetic non-corrective contact lenses.

Cosmetic contact lenses do not have any effect in improving the eyesight of a wearer. Instead they alter the colour and appearance of the eyes. However, while the contact lenses do not alter the wearer's eyesight, they do interact with the eye in the same way that a corrective contact lens would. This means that cosmetic lenses have the same health risks as corrective contact lenses, but despite the risk of complications and injury, cosmetic lenses are not listed as class II medical devices under the Food and Drugs Act and are therefore not subject to regulation by Health Canada.

As the New Democrat consumer protection critic, this obvious gap in the consumer protection regime is worrying. There is a large amount of research detailing the problems that can occur from the improper use of cosmetic contact lenses, such as using lenses that are not suited for a particular individual, using lenses that are not the proper size for the wearer or not fitted correctly, or wearing contact lenses which are of a questionable quality from an unknown supplier.

It is also often the case with these cosmetic contact lenses that critical information and proper instructions. For example, on how to put the lenses in, remove them and clean them are not included with the contact lenses.

By amending the Food and Drugs Act to classify cosmetic contact lenses as class II medical devices, it would mean they would be regulated in the same way as regular corrective lenses. This would mean that all cosmetic lenses sold in Canada would need to be licensed through Health Canada and the distributors of cosmetic lenses would require a licence in order to supply them.

To understand the dangers that occur because of a lack of regulation, we only need look at the statistics related to contact lenses. A 2003 Health Canada report stated that the rate of severe injuries among users of daily corrective lenses was around 1%, while the overall rate of complication was approximately 10%. Report after report has estimated that rate of injury and complications due to infection, inflammation or ulceration is much greater for users of cosmetic contact lenses.

This is not just a public health problem, but an economic one. In 2007 vision loss carried the highest direct cost to Canada's health care system, more than any other disease. Given that 75% of vision loss is preventable, regulations to protect the users of cosmetic contact lenses would go a long way to saving people's eyesight and money, as well as public money.

That brings me to the great work that is done in my riding by the CNIB. I think of Paul Belair, executive director, who would over and over again tell people of the importance of what was talked about earlier: preventive regulations to protect users of cosmetic lenses and the eyesight of Canadians because eyesight is so crucial.

I applaud the member for Sarnia—Lambton for bringing forward this legislation, but it begs the question as to where the government was on this issue in the past. This is not an issue that the government was blindsided by. In 2000 Health Canada issued a health warning about cosmetic contact lenses and recommended they only be used under the supervision of an eye care professional. Then, in 2003, Health Canada recommended the federal government should regulate cosmetic contact lenses.

What does that mean? It means both the current government and the previous Liberal government simply failed to act on this issue against the recommendations of their own departments. When we think of all the opportunities that have occurred in the last 12 years for a government to introduce this simple change, it speaks volumes about how little interest those governments had in protecting consumers.

Once again, while I applaud the MP for Sarnia—Lambton for bringing forward the bill, but I am deeply troubled that we have to address this issue in private members' business in 2012. Put simply, it never should have come to this point.

It is important to realize that the bill is really only a first step, an important step, but still just a first step all the same. The prescribing and dispensing of cosmetic contact lenses is controlled by the provinces and territories. As such, if this change becomes law, the prescribing and dispensing of cosmetic contact lenses would fall to those provincial health departments. This means that any long-term plan to improve upon the quality and safety of cosmetic contact lenses must be designed in coordination between the different levels of government, as the only way to establish an effective regulatory regime is through the federal government working actively with the provinces.

However, this requirement also raises a more worrying question in the long run. As the government has failed to act appropriately in bringing forward the legislative changes needed to regulate cosmetic contact lenses, how can we expect it to work with the provinces and build a long-term regulatory plan for them? It makes me wonder.

Now, I am sure Health Canada will be on top of the issue, just as it was in its 2000 and 20003 reports, but will there be political leadership from the government to act, to work with the provinces to come up with comprehensive legislation that will protect Canadian consumers? Given its track record on this issue and many other consumer protection files, that scenario seems doubtful.

The list of consumer failures that the government has made is shocking. It has turned a blind eye to gouging at the gas pumps. It has let banks walk away from an independent and impartial ombudsman system, avoiding regulating credit cards by announcing a voluntary code of conduct which was designed behind closed doors with the credit card issuers. It wasted years before implementing all-in-one pricing for airlines. Then in last week's budget, it slashed $56.1 million in funding to the Canadian Food Inspection Agency.

Trusting the government to act in a proactive manner to protect consumers using cosmetic contact lenses, as much as I would like to, just seems foolish given its past action, or more properly, its lack of action.

I am very happy to support the initiative of the member for Sarnia—Lambton in bringing forward this legislation. It is a low cost, high reward change in the current legislation. However, it is indicative of the government's lack of adequate consumer protection policies that we are dealing with this issue in this private members' business. We need to continue to push the government to be more proactive when it comes to protecting Canadians and protecting consumers.

Health
Committees of the House
Routine Proceedings

February 17th, 2012 / 12:10 p.m.
See context

Conservative

Joy Smith Kildonan—St. Paul, MB

Madam Speaker, I have two reports.

I have the honour to present, in both official languages, the fourth report of the Standing Committee on Health in relation to Bill C-313, an act to amend the Food and Drugs Act (non-corrective cosmetic contact lenses). The committee has studied the bill and has decided to report the bill back to the House with amendment. I am very pleased with the hard work that has been done on the committee.

I also have the honour to also present, in both official languages, the fifth report of the Standing Committee on Health in relation to Bill C-278, an act respecting a day to increase public awareness about epilepsy. The committee has studied the bill and has decided to report the bill back to the House with amendment.

Food and Drugs Act
Private Members' Business

January 31st, 2012 / 6 p.m.
See context

NDP

Libby Davies 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.

Food and Drugs Act
Private Members' Business

January 31st, 2012 / 6:05 p.m.
See context

Liberal

Geoff Regan 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.

Food and Drugs Act
Private Members' Business

January 31st, 2012 / 6:15 p.m.
See context

Newmarket—Aurora
Ontario

Conservative

Lois Brown 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.

Food and Drugs Act
Private Members' Business

January 31st, 2012 / 6:30 p.m.
See context

Lotbinière—Chutes-de-la-Chaudière
Québec

Conservative

Jacques Gourde 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.

Food and Drugs Act
Private Members' Business

January 31st, 2012 / 6:40 p.m.
See context

Conservative

Patricia Davidson 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.

Food and Drugs Act
Private Members' Business

October 31st, 2011 / 11:05 a.m.
See context

Conservative

Patricia Davidson Sarnia—Lambton, ON

moved 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.

Mr. Speaker, today, I am honoured to speak in support of my private member's bill, Bill C-313, An Act to amend the Food and Drugs Act (non-corrective cosmetic contact lenses), in order cosmetic or decorative contact lenses under the same medical device regulations as corrective contact lenses.

I thank the professionals within the eye care community who have contacted my office in recent weeks with their kind words of support for my private member's bill.

Each member in the House today has representatives of the eye care industry in their riding, and I hope members will heed their warnings about the dangers of the incorrect use of decorative contact lenses that we are hearing more about each day in news reports and medical studies.

Bill C-313 has gained the support of three eye care organizations representing various professionals from the eye care industry. The Canadian Association of Optometrists, the Opticians Association of Canada and the Canada Opthalmological Society are important stakeholders in any discussion on eye care related to their profession.

Today, I intend to share medical evidence with hon. members that will show the clear need for the provision sought after by Bill C-313.

Before we discuss Bill C-313 further, I want to take members back to a different time and place, to the autumn of 2007 in the 39th Parliament of Canada. It was during that period that the concerns of eye care professionals from across Canada were first brought to my attention. At the time, I was an active member of the Standing Committee on Health.

There were many concerns that were brought forward to the parliamentarians on that committee, and while all the concerns were important, I was particularly seized by the concerns that were brought to me by the professional eye care organizations in relation to the lack of regulatory oversight on what were called non-corrective cosmetic contact lenses.

It is very easy to break down the main concern brought forward to me all those years ago. A cosmetic contact lens is identical to a corrective lens in terms of its impact on the human eyeball, with the only difference being that it does not correct a sight imbalance.

However, despite the fact that they are identical to a corrective lens, these cosmetic lenses were and, to this day, continue to be free of regulatory oversight similar to the provisions in place for corrective lenses.

It was with this simple fact in mind that I began work in 2007 to further understand the risks of cosmetic contact lenses. We must remember that cosmetic, decorative and plano contact lenses are all referring to the same product. I will use all three terms in my discussion today.

After extensive study, liaising with health researchers and eye care professionals, meeting with our own experts from Health Canada and engaging with the opposition health critics, I developed a strategy that would ensure that Canadians' eye health would be protected. The result was private member's Motion No. 409, which proposed that cosmetic lenses should be classified as medical devices and be regulated accordingly under the Food and Drugs Act.

The actual text of Motion No. 409 read as follows:

That, in the opinion of the House, the Minister of Health should regulate non-corrective, cosmetic contact lenses as medical devices under the Hazardous Product Act or the Food and Drugs Act.

The motion passed unanimously on March 7, 2008, in a fractured minority Parliament, no less, which I believe is a testament to the fact that this is not a political issue. Rather, we are discussing a human health issue that could impact many Canadians, especially our youth, which I will speak to shortly.

Due to the importance of the motion to Canadians' health, I was able to obtain the full support of all the opposition parties and their health critics, in addition to the support of the government and the Minister of Health. Today, I seek that same support from across the aisle.

I was pleased that the government acted upon the unanimously passed motion. It was in 2008 that the Government of Canada, upon advice from Health Canada, introduced my motion as an amendment to the omnibus Food and Drugs Act amendment in the former Bill C-51, which was introduced in April 2008, but which also died on the order paper upon the election in the fall of 2008.

It was unfortunate that having already had my private member's spot used in the 39th Parliament, I found myself near the bottom of the long private members' business list. This meant I would not have the ability to bring this legislative change forward for some time.

Moving ahead to late 2010, now in the 40th Parliament, it became evident that I would possibly have the ability to bring forward private members' business. Knowing that I had unfinished business, I reached out to the professional eye care organizations to begin discussions on the types of legislative remedies that could be brought forward.

My main concern was to ensure that my private member's bill would adequately and fully address the concerns held by myself, other parliamentarians and thousands of eye care professionals across Canada.

Of course, we have had another election since then and, upon being re-elected by the citizens of Sarnia—Lambton, I found myself returning to a new House of Commons in the 41st Parliament. I also found myself near the top of the list for private member's business, meaning that months of research and effort through my office were about to be realized in terms of finally bridging the regulatory gaps that exist for decorative non-corrective lenses.

The culmination of this long process now stands before the House of Commons for debate. With this brief background on my bill now before the House, I would like to discuss Bill C-313, An Act to amend the Food and Drugs Act (non-corrective cosmetic contact lenses), with everyone today.

I can sum up the situation regarding the need for my legislation in one sentence regarding non-corrective cosmetic lenses. National distribution of these products without professional oversight, fitting and training significantly increases the risk of public harm.

The difference between 2007, when I first brought my private member's motion forward, and 2011, is that I now have the peer reviewed medical evidence to back up my claim. Today, we now know that the warnings on cosmetic lenses dating back to October 23, 2000 by Health Canada are, in fact, quite well warranted and now demand a legislative recourse 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 due to unsafe handling and wearing an improperly fitted lens in one's eye, along with the lack of professional oversight when these products are initially obtained by the consumer, includes the following: conjunctivitis, corneal abrasions, giant papillary conjunctivitis, microbial keratitis and other forms of bacterial, allergic and microbial infection 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 these product through opticians and regulatory bodies. What has now been shown as fact through peer reviewed studies is that non-prescribed decorative or cosmetic lenses are much more likely to cause complications to users for a combination of factors, including lack of oversight on the product for the consumer in terms of how to use the product and in terms of the potential quality of the product.

It should be noted that some businesses import cosmetic lenses from parts of the world where production of the device to be fitted into a human eye does not necessarily take the best precautions in terms of the quality of their product, leading to the rise of bacterial infections and microbial issues. These companies make large profits off a consumer base that is woefully unaware of the potential harm they are causing to their own eye sight.

A recent search on the Internet for cosmetic contact lenses Canada brought up over one million hits. The top hits on the search were for several large marketing and distributing companies that sell cosmetic lenses made in certain regions not as well-known as Canada for having strong consumer protection measures. This is extremely concerning and we can be sure that the regulatory oversight that Bill C-313 would provide should help to shed some light on the businesses that are importing and providing these products to consumers with little to no oversight or concern for the consumer of their product.

To date, we have now seen several studies on the issue of 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 that point was still being debated by public health officials, that the level of risk associated with the use of cosmetic contact lenses was comparable to that associated with corrective lenses and maybe potentially higher. The main issue here is that corrective lenses are subject to professional monitoring and proper regulatory oversight. Cosmetic lenses are not.

The Dillon report also called for the following risk management strategies: individual screening should take place before a cosmetic lens is sold to a customer; proper fitting should be ensured; adequate instruction on cleaning and sterilization should occur; familiarization with recognition of potential symptoms related to the condition of the eye; and, regular aftercare.

To date, not one of the suggested risk management strategies called for in this report have been adopted, while corrective lenses are strictly defined by Health Canada. With this in mind, we must all ask the question why this has been allowed to occur for so long despite the long-standing pleas of the eye care industry and medical researchers.

To recap our discussions thus far, the main concerns Bill C-313 seeks to redress is that cosmetic or decorative cosmetic lenses are being dispensed without a prescription or fitting from unlicensed vendors. Consequently, uninformed lens wearers are experiencing acute, vision threatening infections and inflammation.

This has now become an accepted fact due to a recent study that appeared in Acta Ophthalmologica, the official medical journal for optometrists and ophthalmologists in Europe. In this study, research conducted at the Department of Opthalmology at Strasbourg University Hospital in Strasbourg, France, clearly indicated that:

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

The study in question focused on a bacterial infection known as microbial keratitis, a common yet preventable infection that can occur in wearers of contact lenses, both corrective and non-corrective cosmetic varieties. This study has shown that wearers of cosmetic lenses were at higher risk, with 79% of the controlled group of cosmetic contact lens wearers suffering from corneal scraping. However, the study showed that only 51% of corrective contact lens wearers suffered similar affects. Meanwhile, more than half of the cosmetic lens wearers who were shown to have suffered corneal scraping were also shown to have serious microbial infection as well in the eye.

The study concludes that the increasingly documented risks of easily accessible cosmetic contact lenses were a serious concern in France where the study took place.

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

Considering the medical evidence that clearly shows the need for the provisions contained in Bill C-313, it is important to note that Canada is at least a decade behind other jurisdictions such as the United States and Europe in achieving proper regulations for cosmetic, decorative or plano lenses.

No matter what we want to call them, it is scientific fact that there are issues with these lenses being improperly sold and used in our nation. The risk was sufficient enough that, in 2000, Health Canada issued a public health warning. In 2003, a human health risk assessment was conducted. In 2008, this House of Commons unanimously agreed with the viewpoint that cosmetic lenses were indeed a risk to Canadian consumers and that we must take action.

Although I have spoken at great length as to the risks of cosmetic contact lenses and, therefore, the need for the provisions of Bill C-313, I will share with the House a quote from Dr. Lillian Linton, president of the Canadian Association of Optometrists, who stated:

This is about people’s eyesight…and in most cases young 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.

I could not agree more with Dr. Linton.

The time has come for us as parliamentarians to join together to support Bill C-313 so that we can ensure that much needed oversight is finally brought forward. In doing so, Canada can reclaim the proper regulatory powers over the importers of these products who so callously flood the Canadian market while doing untold damage to hundreds of thousands of young Canadians' eyes, completely unbeknown to most consumers, unfortunately.

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

Food and Drugs Act
Private Members' Business

October 31st, 2011 / 11:40 a.m.
See context

Conservative

Michael Chong Wellington—Halton Hills, ON

Mr. Speaker, I am pleased to speak to Bill C-313, An Act to amend the Food and Drugs Act (non-corrective cosmetic contact lenses). I congratulate the member for Sarnia—Lambton for introducing this private member's bill. It is not often that we get a chance to introduce private member's bills. This one is very well thought out. The member is a strong representative of her riding. I remember visiting her five or six years ago. She served for some time as warden of Lambton County and also as mayor of Wyoming in Plympton-Wyoming for 16 years. She has to be one of the longest serving mayors in Ontario. Certainly she is the first mayor to serve as the mayor of Plympton-Wyoming.

Many members from the west may be surprised to learn that the very first commercial oil well ever drilled not just in Canada but in North America was drilled in Oil Springs, Lambton County in 1858. The oil industry and energy industry really started in southwestern Ontario, which is still home to many petrochemical and refinery companies. It is a great area of the world that has produced strong baseball teams, strong farm families, and now a strong member of Parliament who has introduced a very good piece of legislation.

All members in the House would agree that eyesight is a gift and it is not something we should ever take for granted. We would also agree that products we put directly on our eyes should be of high quality and safe to use for those purposes. We would also agree that because our eyesight is so very important, consumers should have the information necessary to make an informed decision about whether or not to purchase the product, and once they have, they should also know how to use that product in a safe way.

For all those reasons, this private member's bill is important legislation. It would help us address a long-standing safety issue related to the sale and use of these products. Cosmetic lenses, also known as non-corrective contact lenses, are used to change the appearance of the eye. They are available in a wide range of colours and designs. They are used primarily to make a fashion statement. Today is Halloween and tonight many Canadian children and adults will either go trick or treating or to a Halloween party. Many people will be wearing costumes. These costumes often include cosmetic lenses.

While I have never used them myself, I have seen them and they sometimes can be disconcerting. I have seen red vampire eyes, yellow cat's eyes, even starry eyes. There is a wide range of cosmetic lenses. They often are purchased over the Internet or at a costume retailer, as opposed to corrective lenses which are purchased at drug stores. Unlike corrective contact lenses, there are no labelling requirements to make consumers aware of the potential health and safety risks, or to provide instructions as to their proper use and care.

Cosmetic lenses are identical to corrective lenses, with one exception. Cosmetic and corrective lenses are used in the same way and pose the same risks to human health. The only difference is that cosmetic contact lenses do not correct vision. Even though these two products pose a similar risk, they fall under two different sets of regulations and regulatory regimes. That is the problem this bill would fix.

On the one hand, corrective lenses are considered to be medical devices and are regulated under the Food and Drugs Act and the medical devices regulations. On the other hand, cosmetic contact lenses are considered to be consumer products and are regulated under the Canada Consumer Product Safety Act. The bill before us today would help to harmonize those two sets of regulations by bringing both cosmetic and corrective lenses under the Food and Drugs Act and the medical devices regulations so that there would be greater clarity for consumers and greater health and safety standards for Canadians. That would mean both cosmetic and corrective lenses would be subject to the same rules for health and safety.

In the last Parliament, our government introduced the Canada Consumer Product Safety Act, which is strong legislation. It came into force earlier this year with support from both sides of the House. It strengthens the product and the protection of health and safety of Canadians by requiring suppliers of consumer products to report any safety-related incidents, including serious injuries or deaths, and to report any recalls or any other regulatory action in other jurisdictions.

As a consumer product, cosmetic lenses are regulated under the new legislation. It means that defective cosmetic lenses could be recalled by Health Canada if they posed an unreasonable danger to human health and safety.

However, while the new legislation will give Health Canada the powers of recall and while it is a much improve regulatory framework under which we will regulate consumer products in Canada, it does have one hole in it. The problem is it does not require companies selling these cosmetic lenses to meet the same labelling and consumer instruction standards. That is exactly what Bill C-313 would fix. It would fix this problem by regulating cosmetic lenses as medical devices under the Food and Drugs Act and the Medical Devices Regulations.

It would also require companies to report problems and provide additional information if Health Canada requested it. It would also ensure that all cosmetic lenses met the same regulatory standards as corrective lenses, in other words, the same standards as class II medical devices. Most important, it would ensure that proper information be contained on the packages to allow consumers to make an informed choice as to whether to buy the product and if they bought the product, what the proper use of the product would be to ensure eye safety.

Bill C-313 would require that cosmetic lenses meet specific labelling requirements, including instructions for use on the product label. It would provide consumers instructions on how to use the product safely and effectively, which would go a long way in reducing the risks associated with cosmetic contact lenses.

It is important to point out one thing. The legislation would, in no way, mandate prescriptions for cosmetic lenses. Whether to require prescriptions for lenses is a decision of the provinces and the legislation would not change that fact.

However, there are two other important aspects of the legislation that are worth pointing out.

The legislation would simplify the Canadian regulatory framework by bringing both corrective and cosmetic lenses under the same regulatory framework, as opposed to the current situation, which is where one is regulated under one act and the other is regulated under another act. This would ensure that both products would be regulated in a similar fashion.

The second thing it would do is harmonize our regulations with our largest trading partner. Since 2005, all cosmetic lenses sold in the United States have been regulated by the Food and Drug Administration. Currently, many Canadian consumers who purchase these products are confused because many of these cosmetic lenses have labels on them that say “FDA approved”. They are confused as to whether they are safe for use in Canada. They are also concerned when they see products that have not been labelled in a similar fashion. The bill would ensure harmonization of cross-border regulations between Canada and our largest trading partner.

I want to once again congratulate the member for bringing forward the legislation. It would allow consumers to continue to have access to high-quality, safe cosmetic lenses. It would simplify our Canadian regulatory framework. It would harmonize the regulations with that of our largest trading partner. Most important, it would require full information be put on the package to allow consumers to make an informed decision about purchasing the product and, once purchased, ensure that consumers would have all the information required in order to use these cosmetic lenses safely.

For all these reasons, I encourage members of the House to support the legislation. I congratulate the member for bringing it forward.