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.

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, an excellent resource from the Library of Parliament. You can also read the full text of the bill.

Food and Drugs ActPrivate Members' Business

April 4th, 2012 / 6:55 p.m.


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NDP

Megan Leslie NDP Halifax, NS

Madam Speaker, I am very pleased to speak to the bill today, especially on the heels of my colleague, the member for Sudbury, who has done amazing work on consumer protection issues for Canadians. In fact, I would call him a true consumer advocate. Therefore, it is great to speak after his speech on the consumer protection issues involved in the bill.

I have learned a lot from the bill. I did not know that cosmetic contact lenses were not a class II medical device. In fact, I did not know what a class II medical device meant, despite the fact that I have worn coloured contacts. I am wearing contacts right now, although this is my natural eye colour. I did not know any of this because I was able to purchase my coloured contacts many years ago from my optometrist. That is not the situation that we have with this bill.

Because I needed corrective lenses, I had to see an optometrist. I have to meet with him regularly and get regular checkups. I was instructed on how to properly handle my contact lenses, how to insert them and how to clean them properly. In fact, he always advises me when there is a new type of contact lens that comes out, which allows more oxygen into my eye. It is not something I know anything about. I trust his expert advice, when he says there is a new contact that is be better for my eyes because it does allow more oxygen in. I learned all of this because they are corrective lenses. When I was in high school, I had a slight green tint to my contacts, but they were still corrective lenses, so I still received the proper training and proper monitoring.

Last year I had a regular checkup with my optometrist. When he took a picture of my eye, there was a dark spot on it. He said that it could have been a freckle or it could have been something quite serious, but that he would not know until time had passed to see if the size of it had changed. Immediately, I was so terrified that I did not want to go back to see him. I know that is not logical, but sometimes we are not logical. Sometimes we just react with our gut emotions. I did not want to know if this was something dangerous. It made no sense, but it was how I felt.

However, because I had to see him to get my prescription renewed to order new contacts, I was forced into the position where he had to do another checkup. That is a really positive thing.

Some people complain that we might be regulated to death. In the situation like this, we are trying to protect Canadians to ensure they are healthy and safe.

If someone like me, an informed and educated consumer, a consumer who is familiar with the product, is too scared to go back to get a photo taken of the back of my eye to see if there was something wrong, too scared that I wanted to avoid knowing the truth about the health of my eye, imagine, for example, young people, large consumers of non-corrective or cosmetic contact lenses, not knowing how to handle them properly or not knowing the risks involved, and there are incredible risks. They think it is just for Halloween so they will get fun lenses so they can look like a cat, or a vampire or whatever. It seems pretty harmless. People wear contacts all the time. However, they can have pretty serious eye injuries. They can have an allergic reaction. There could be a bacterial infection. They could have inflammation or swelling of the cornea, scratches on the cornea, even loss of sight. However, the one thing with the Halloween contacts is some of these reactions can happen in as little as 24 hours.

We think it is just this silly little costume thing, but this is very serious. It is eye health. We only have one shot at this. Imagine having some of those kinds of impacts happen in as little as 24 hours. Some of these things are very difficult to treat and sometimes they are permanent.

I watched a CBC piece about a woman who went to Panama to get permanent contact lenses. There is an operation where a hard disc is inserted in the eye to permanently change the colour.

This woman is now legally blind. She can only see shapes and colours. She has had to have numerous surgeries, one surgery to take these disks out and then numerous cornea surgeries. It was heartbreaking to see. This was a young beautiful woman. This is how desperate people are sometimes to alter themselves cosmetically, that they go to such lengths. This surgery cannot be done in Canada, thank goodness. However, people actually spend their savings to go down to Panama so they can have blue eyes. It is hard to imagine, but that is the reality.

If that is the reality, we need to be doing everything we can to make sure Canadians are safe. When it comes to corrective contact lenses, absolutely they should be a class II medical device. It only makes sense.

My colleague from Sudbury used the term “low cost, high reward change”. This is not going to cost us anything. It is something that has been demanded. It has been asked for. Health professionals have been warning Canadians for the last 10 years about these risks. They have been urging the government to actually come forward and make these changes.

One of the first responsibilities of government should be to protect the health and safety of Canadians from potentially dangerous products. That is a no-brainer. It does not matter if people believe in big government or small government. This is fundamentally about what government should be there for. It is there to help us, to protect us, to make sure we are safe.

One thing about the bill that I think we have heard some folks chat about is that this bill is only the first step because, by and large, contact lenses are regulated provincially. It is a good first step. It is a necessary first step. However, what we are going to have to see is the federal government taking on more of a leadership role and working with the provinces to make sure there is an effective regulatory regime established for cosmetic contact lenses.

On that point, I would note the leadership shown by the member for Sarnia—Lambton in bringing forward this bill. I commend her for what she has done. Effectively what she has done is stepped up to the plate where her minister has failed to. We have been hearing about this for years. In 2000, Health Canada issued a warning. Health Canada issued a warning about cosmetic lenses and recommends that people only use them under the supervision of an eye care professional. Where is the Minister of Health on this? She is utterly absent in all the mandates where she has been serving, utterly absent on stepping in to play a leadership role in protecting the health of Canadians.

I just wanted to add those who have actually been championing this in civil society, to say that this is the kind of leadership we need from our government: the Canadian Association of Optometrists, a huge champion of this; the Canadian Ophthalmological Society; and the Opticians Association of Canada. They have all been publicizing the risks that are associated with cosmetic contact lenses, and they have all been asking Health Canada to regulate them under the Food and Drugs Act.

They recognize the jurisdictional issues here, too. By and large, it is the provinces that would be regulating contact lenses. They are saying both federal and provincial regulations are needed to treat cosmetic contact lenses the same as corrective lenses.

Going back to the evidence, I talked about some of the groups that are actually bringing forward this idea and being champions. There really is an abundance of evidence and research—

Food and Drugs ActPrivate Members' Business

April 4th, 2012 / 7:05 p.m.


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The Deputy Speaker Denise Savoie

The time provided for the consideration of private members' business has now expired, and the order is dropped to the bottom of the order of precedence on the order paper.

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 ActPrivate Members' Business

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


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Liberal

Hedy Fry Liberal 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 ActPrivate Members' Business

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


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NDP

Don Davies NDP 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 ActPrivate Members' Business

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


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Conservative

Patricia Davidson Conservative 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 ActPrivate Members' Business

May 31st, 2012 / 5:30 p.m.


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The Acting Speaker Bruce Stanton

The question is on the motion. Is it the pleasure of the House to adopt the motion?

Food and Drugs ActPrivate Members' Business

May 31st, 2012 / 5:30 p.m.


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Some hon. members

Agreed.

Food and Drugs ActPrivate Members' Business

May 31st, 2012 / 5:30 p.m.


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The Acting Speaker Bruce Stanton

I declare the motion carried.

(Bill read the third time and passed)