An Act to amend the Food and Drugs Act (non-corrective contact lenses)
Patricia Davidson Conservative
Introduced as a private member’s bill.
This bill has received Royal Assent and is now law.
Comments by the Member for Wellington—Halton Hills
June 6th, 2013 / 3:10 p.m.
Nathan Cullen Skeena—Bulkley Valley, BC
Mr. Speaker, I rise on a question of personal privilege that I think will have some relevance to my colleague across the way, the House leader for the government, as well as the House leader for the Liberal Party.
I rise on a question arising from some troubling insinuations made last night over the course of debate. I have been reviewing yesterday's debate and I was surprised and, not somewhat, but very concerned by some serious allegations that were made by one of my colleagues across the way. These statements call into question the integrity of the House and the House leaders and I wanted to raise them with you today, Mr. Speaker, as soon as possible.
During the debate on vote 1 on the main estimates, while referring to Bill C-290, an act to amend the Criminal Code sports betting, the MP for Wellington—Halton Hills mentioned:
In fact, what transpired on Friday, March 2, 2012, was that the House leaders worked together to force debate to collapse before the full two hours of third reading had transpired, preventing members like me from “standing five” to request a full standing division on that piece of legislation.
By saying that, the member for Wellington—Halton Hills is insinuating that the House leaders had come up with some kind of conspiracy to bypass the parliamentary process. Not only does this show a lack of understanding of the legislative process, it puts the credibility of the officers of the House into doubt. Moreover, Mr. Speaker, it puts your credibility into doubt by insinuating that you would allow such a conspiracy to take place.
My friend across the way knows this place well and knows the rules that govern the House. He has been here for some time now, so I find it passing strange that he has gone so far as to suggest that there was a coordinated effort to trample his rights as a duly elected member of Parliament. Perhaps a brief review of what happened in this case can help clarify the situation for him and for all, and perhaps invoke some retraction or apology to both yourself, Mr. Speaker, and the House leaders.
Bill C-290 was debated at second reading on November 1, 2011. During the debate, all MPs had the opportunity to express themselves on this bill. This opportunity was seized by the member of Parliament for Windsor—Tecumseh, the member for Windsor West, the member for Moncton—Riverview—Dieppe, the member for Edmonton—St. Albert and the member for Charlottetown. Following these interventions, because no other member rose to speak, the Speaker put the question to the House, as is proper.
This is the normal procedure at any time when no further members rise to speak on a bill. If the debate collapses, the bill can be adopted or rejected at that point, or a recorded division can be requested by any five members in the House. In the case of this bill, there was not a single MP from any party who expressed their opposition to the bill being read a second time and referred to the committee.
The member for Wellington—Halton Hills could have expressed his concerns at this time by simply standing up. He chose not to. During the committee study, any MP could have submitted their concerns on the bill or encouraged the committee members to recommend that the House not proceed with the bill at all. This is good legislation, so no member availed themselves of this opportunity and the bill was passed by the committee, once again without opposition.
Members had a third opportunity to express themselves at the report stage on March 2, 2012. Indeed, as prescribed in the Standing Orders, when a bill comes back from the committee and there are no amendments, the Speaker automatically puts the question at report stage. Once again, the bill passed through this stage without any opposition whatsoever.
The debate at third reading provided a fourth chance for the members to examine and debate the bill. Once again, representatives from all three recognized parties took the opportunity to address the bill. It was a lively debate. The member for Wellington—Halton Hills, as well as other MPs, had the chance to give a speech on the bill at that point, but they did not. For a fourth time, the bill was passed by members of the House, without opposition.
The MP for Wellington—Halton Hills had all of these occasions to speak on Bill C-290 and to move any amendments or changes, but he chose not to. The order paper shows us well in advance when a bill is to be debated. It is not a secret. However, instead of standing to speak his voice, he chose to stay in his seat or not be present. Now he claims that there was somehow a conspiracy against him, blaming his House leader, myself and the House leader for the Liberal Party of having conspired to prevent him the opportunity to use his democratic voice.
Moreover, the MP for Wellington—Halton Hills seems to think that it is unheard of for a private member's bill to go through all steps without a standing vote. Since the beginning of this Parliament, at least two bills from opposition MPs went through all stages in the House of Commons without a standing vote. This was the case for Bill C-278, An Act respecting a day to increase public awareness about epilepsy, as well as Bill S-201, An Act respecting a National Philanthropy Day.
There was also Bill C-313, An Act to amend the Food and Drugs Act (non-corrective contact lenses) and Motion No. 319 from the MP for Ottawa—Orléans.
These four private members' business items all passed through the legislative process without a standing vote in the House. We heard no such cries of conspiracy or condemnation from the member who is raising the complaints now or from any other member because this is the practice of the House. My friend from Ottawa—Orléans knows this practice well and used it.
These assertions that have been made are broad sweeping and undermine the integrity of the House officers of the various parties by calling into question the work that we undertake on behalf of our parties. The member for Wellington—Halton Hills is calling into question the integrity of this House and the legislative process, a process he knows well. I hope that this is not what the member was suggesting or insinuating last night. Maybe it is just that the member has misplaced certain rules of the House.
If he feels that his rights to express himself in the House have somehow been violated, I also invite him to discuss this with his House leader or others who try to maintain an orderly and conducive debate in this place. He does not have to try and intimidate those of us in this House. We New Democrats, more often than anyone else in this place, believe in and defend the institution and the rights of members of Parliament to speak. We have opposed the 42 motions that have been moved by this government to shut down debate every single time. The insinuation that there is somehow a conspiracy to prevent certain members from speaking on a piece of legislation, simply because they are in opposition, is both offensive to myself and I would suggest to the other House leaders, although they will have their own positions and feelings about this.
I would also argue that this assertion puts your credibility into doubt by insinuating that somehow you would allow such a conspiracy to take place. I believe that these allegations constitute a prima facie breach of privilege.
If you come to the same conclusion that I have, I would be prepared to move the appropriate motion to have this studied by the Standing Committee on Procedure and House Affairs.
I look forward to the interventions by my colleagues across the way.
Food and Drugs Act
Private Members' Business
May 31st, 2012 / 5:25 p.m.
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
May 31st, 2012 / 5:15 p.m.
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 / 5:15 p.m.
Hedy Fry Vancouver Centre, BC
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.
The House resumed from April 4 consideration of the motion that Bill C-313, An Act to amend the Food and Drugs Act (non-corrective contact lenses), be read the third time and passed.
Food and Drugs Act
Private Members' Business
April 4th, 2012 / 6:50 p.m.
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.
Food and Drugs Act
Private Members' Business
April 4th, 2012 / 6:40 p.m.
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 / 6:35 p.m.
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.
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 / 6:05 p.m.
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.
The House proceeded to the consideration of Bill C-313, An Act to amend the Food and Drugs Act (non-corrective contact lenses), as reported (with amendment) from the committee.