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.
Mr. Don Davies (Vancouver Kingsway, NDP):
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.