Bill C-51 (Historical)

An Act to amend the Food and Drugs Act and to make consequential amendments to other Acts

This enactment amends the Food and Drugs Act to modernize the regulatory system for foods and therapeutic products, to strengthen the oversight of the benefits and risks of therapeutic products throughout their life cycle, to support effective compliance and enforcement actions and to enable a greater transparency and openness of the regulatory system.
It also amends other Acts in consequence and includes transitional provisions and coordinating amendments.

Food and Drugs Act

[Alistair MacGregor, NDP, Cowichan—Malahat—Langford, BC]

Madam Speaker, I am very pleased to speak to Bill C-368. I would like to thank the member for Red Deer—Lacombe for bringing it forward for the House's consideration.

The reason I am very pleased is that the issue of natural health products has garnered a lot of attention in my riding of Cowichan—Malahat—Langford. I have had a lot of constituents and local businesses approach me concerning this issue in particular. I am pleased to be able to stand here, as their elected representative, and let my constituents know that I will be supporting the bill at second reading.

I was also very pleased to be able to add my name as a joint seconder to the bill. To fulfill the wishes of my constituents, I will be voting to send it to committee for further study.

What are we talking about when we say “natural health products”? I have always thought it a weird thing that they are regulated under a statute such as the Food and Drugs Act. They are not really a food, nor are they a drug. They occupy a special place for many people. We must face that humans have had relationships with natural health products dating back thousands of years. Many of these products have a very special place in human history, and a lot of cultures have very long relationships with them.

Today, in the modern world, natural health products often come in a variety of forms, such as tablets, capsules, tinctures, solutions, creams, ointments and drops. There is quite a large variety for people to pick and choose from. They are often made from plants, but they can also come from animals, from micro-organisms and from marine sources. They include vitamins and minerals, herbal remedies, homeopathic medicines, traditional medicines, probiotics and other products, such as amino acids and essential fatty acids. They are found in many everyday consumer products.

Let us come to the bill in question, Bill C-368. As shown in the summary, it would amend the Food and Drugs Act to provide that natural health products are not therapeutic products within the meaning of that act and, therefore, are not subject to the same monitoring regime as other drugs.

Before we get into the substance, we need to take a little history lesson on how we arrived here. I want to say that both Conservatives and Liberals have run into trouble when trying to regulate natural health products. In fact, the previous government, under Harper, learned this lesson very quickly back in 2008 when it introduced Bill C-51. That was also an act to amend the Food and Drugs Act. Under Bill C-51, the term “therapeutic products” encompassed a range of products sold for therapeutic purposes, including drugs, medical devices, biologics and natural health products. In the end, because of an election, that bill was never adopted. However, I believe the Harper government at that time learned its lesson because of the uproar that came in response to Bill C-51, and it did not attempt to change Canada's regulations for natural health products again while in government.

What the Harper government did do, in 2014, was introduce Bill C-17 to amend the Food and Drugs Act. It was also known as Vanessa's Law. This introduced a definition for the term “therapeutic product”, but what was different this time was that the definition was worded in such a way that it did not include natural health products, within the meaning of the natural health products regulations.

We then fast-forward to the present Liberal government and Bill C-47. That bill, in a clause buried deep within a budget implementation act, again amended the term “therapeutic product” to make sure that the exemption from the natural health products regulations was actually removed. This has caused much of the uproar we see today.

I want to point out, as I said in my intro, that natural health products have a long history of use in Canada as low-risk, affordable methods of promoting well-being. It is very important that I stand here today and say unequivocally that they must remain accessible to all Canadians. I am proud to be a member of a caucus, the NDP caucus, that has long supported an appropriate regulatory category for natural health products to certify their safety and efficacy based on sound evidence, as well as to ensure that they are widely available for those who use and value them.

It is unacceptable that the changes to the regulatory regime under the Food and Drugs Act was snuck into a budget omnibus bill, because it did not allow for proper study. I am glad to see that, because Bill C-368 is a stand-alone, quite simple and easy-to-read piece of legislation, from reading the room, it should have enough votes to send it to committee. We can then have the proper study; hear from Canadians and businesses that sell natural health products, the practitioners involved in this every day; and, finally, get the proper scrutiny that this issue so richly deserves.

I do not want to spend too much longer speaking to the bill, but I want to talk a bit about the people in my riding of Cowichan—Malahat—Langford who took the time to write to my office, phone me personally and come into my office. In particular, I want to recognize a few of the local businesses. Essential Remedies, Benoit and Associates Health Education, some holistic health practitioners, the Community Farm Store, Botanical Bliss, a certified homeopathic practitioner, a naturopathic physician and Lynn's Vitamin Gallery all took the time in the summer of 2023 to come into my office. We had a great round table discussion. It lasted well over an hour. It was really enlightening for me, as their member of Parliament, to hear their views on this subject and learn a little more about why it is so important.

Yes, my immediate family definitely uses natural health products, and I know that many friends and relatives in my immediate vicinity also use them. However, to hear from professionals who work with clients every day about why this issue is so important was particularly enlightening for me. It is also important to note that 71% of Canadians, which is a very big number, have used natural health products, such as vitamins and minerals, herbal products and homeopathic medicines. Therefore, it is important that, when the NHP community speaks to their elected representatives, it represents a very clear majority of Canadians. Based on a proper cross-sampling of the correspondence that I, like many other members, have received, I know that they want their elected representatives to treat this issue with the seriousness that it deserves and give the bill full scrutiny.

Finally, I want to congratulate the NHP community and industry, which have been very actively engaged on this issue through their work. I really want to single out the local businesses in my riding of Cowichan—Malahat—Langford and the constituents who live on Vancouver Island. I congratulate them for their advocacy, for stepping up to the plate and for engaging me as their elected representative, because it has worked. I am proud to say that, in this place, as their elected representative, I will be pleased to vote to send Bill C-368 to committee.

[Peter Julian, NDP, New Westminster—Burnaby, BC]

Madam Speaker, I said earlier, in thanking the member of Parliament for Red Deer—Lacombe, that we support this legislation. We support Bill C-368 for a number of reasons.

I want to start by saying that, as are over 70% of Canadians, I am a consumer of natural health products. I use those products, as 70% of the population does. This includes vitamins and minerals, herbal remedies, homeopathic medicines and probiotics. Many Canadians use traditional medicines, such as traditional Chinese medicines or indigenous medicines, as well. There are a wide variety of products on the market.

As has already been stated, the reality is that we have a very robust natural health product sector that is carefully regulated in a way that ensures that the products are of good quality. That is why, when we look at the natural health product sector, we see so many Canadians consuming them and, at the same time, we see no side effects or downsides to the consumption of those products.

It is because the products are effective. If they are not, we stop using them. I have tried a number of products over the years. Some work really well; others, not so much. As consumers, we have that ability to distinguish and make sure we are choosing products that are appropriate for us.

This is not the pharmaceutical sector. These are not prescriptions that are given out. I have a family doctor who is very good at sometimes suggesting products that are not part of a prescription, but simply a suggestion. He has turned out to be right every single time about the kind of products we can take.

As an example, there is magnesium, which is a vitamin product. My friend from Red Deer—Lacombe mentioned it earlier as well. Some of us are on flights back and forth across the country, travelling 5,000 kilometres twice a week, every month. My colleague from North Island—Powell River is in the same situation. We are going around this planet every month in terms of the amount of time we spend on airplanes, getting back to our constituency to ensure that we are serving our constituents and then coming to Ottawa to do the important work we do here.

The reality is that, when we are doing this, we are in a cramped space. We need to ensure we take magnesium if we want to avoid leg cramps. My doctor was the one who suggested it, and ever since then, I have made sure that I take the appropriate product. It makes sense. I know you agree, Madam Speaker, even though you do not have as far to go when you go back to your constituents.

There is a wide range of products that are available and that make a difference. For consumers who find that their products just are not up to speed, they can change, try another product or simply decide they are not going to use something anymore.

What is already a flourishing and effective sector was diminished by the government incorporating into Bill C-47, an omnibus legislation, these clauses that simply put natural health products in a completely different situation. They are heavily regulated with costs, which a number of speakers have already indicated were absolutely inappropriate. Ever since I have been here, and certainly for years before that, the NDP caucus has decried omnibus legislation.

We saw this under the former Harper Conservative government. We see this under the current Liberal government. There are massive budget implementation acts that are 700 or 800 pages. Incorporated within them are really what I call poison pills. Certain clauses are put in there that ultimately serve as changes in legislation. However, then we can see they have regulations that are not part of Parliament's purview or the government's purview, and they can actually have detrimental impacts.

This was the case with Bill C-47. This was tried before with Bill C-51 under the Harper Conservative government.

The government tried to, very heavily and inappropriately, apply additional regulations to natural health products. That was pushed back on, but with Bill C-47, as omnibus legislation that led to the regulatory changes, we are in the situation that we find ourselves in now, and that has to change. That is why we are supportive of Bill C-368.

What it would do is provide for the kinds of hearings at the committee stage that would allow us to really determine the full extent of how the existing sector is regulated effectively and how detrimental these changes are, both those suggested in Bill C-51 a few years ago and those currently in Bill C-47, to the industry itself, which is a Canadian success story, as well as the impact on consumers who are using these vitamins, probiotics and homeopathic medicines effectively and potentially finding it more difficult to access these natural health products because of the actions of Health Canada and the actions of the government.

As such, it makes good sense to take Bill C-368, to put it in place, to have those hearings, and then to determine what is appropriate. It is very clear that those regulatory changes were absolutely excessive and have had a profound negative impact.

What we are saying is that the government, through Bill C‑47, is taking action with Health Canada without holding consultations and without conducting an impact study or a management fee study. As my colleague mentioned, this means that small businesses that market natural health products are now subject to a regulatory framework that is far better suited to the pharmaceutical industry.

The pharmaceutical industry is the most profitable industry in North America. It makes huge profits, which is why the NDP is pushing for pharmacare. In countries with pharmacare, pharmaceutical companies have been forced to lower their prices. The case of New Zealand, where the price of some pharmaceuticals has dropped by 90%, is often cited.

These pharmaceutical companies are extremely powerful. It makes no sense to establish a regulatory framework that puts small businesses, which are safely selling a whole line of products to smaller markets, on the same footing as big transnational pharmaceutical companies that are raking in huge profits. That is why the government's approach was inappropriate. It was inappropriate to include this small provision in omnibus legislation that is several hundred pages long. The consequences of this regulatory change are unclear, which has led to the outcome before us today.

It is clear to the NDP that this bill is important, because it was unacceptable for that provision to be included in an omnibus bill. It was unacceptable for the former Harper government to do that, and it is unacceptable for today's Liberal government to do the same.

Thanks to the bill introduced by my colleague from Red Deer—Lacombe, we have the opportunity to correct the mistake that was made and to really look at this provision's impact on the natural health product industry. We have the opportunity to determine the financial impact and the impact on consumers. We have the opportunity to see the full impact of the decision that was made last year to include this provision in an omnibus bill. The NDP has been very clear in this regard: We support the bill and we look forward to the important discussions that will take place in committee.

[Dr. Stephen Lucas]

I think it was initially advice provided in Bill C‑51 in 2008. It was not included in Vanessa's Law, which received royal assent in 2014. The department has been working and continues to work to see that these authorities—

[Dr. Joel Lexchin]

I certainly think we need more information about natural health products. I work in an emergency department. When people come in and they say they're taking various natural health products, I really have no idea of, one, the inherent risks associated with those products, and two, how those products interact with any prescription drugs that those people may be taking.

I'm not alone. I think most of my colleagues are in the same position. We definitely need more information about the safety of these products. But I think one of the things that killed Bill C-51 was the opposition from the natural health products community. I would hate to see Bill C-17 killed because of that same kind of opposition. I think we need to move forward with better regulation of natural health products. But I agree that I think it can be done at a later date.

[Sylvia Hyland]

I have just a comment on one of your questions.

The Food and Drugs Act hasn't been amended in, I think, about 50 years. If you are asking, are we lagging behind? We are lagging behind a little in the authorities for Health Canada.

My understanding is that there were more complex bills proposed, Bill C-51, Bill C-52. They were comprehensive, complex, and they weren't enacted. This is a more simplified, to-the-point bill to take a step forward in safety in Canada.

Thirdly, Canada is leading in some ways already. There are only a handful of countries worldwide that post their adverse drug reaction reports online, available to the public and practitioners. Two other countries that I know of are the Netherlands and the U.K., and then there's Canada. We have taken some steps to show leadership worldwide. In the United States they do make the device incidents available online, but not the adverse reaction reports.

I just wanted to share with you a little bit about where Canada sits worldwide.

Protecting Canadians from Unsafe Drugs Act (Vanessa's Law)

[Francis Scarpaleggia, Liberal, Lac-Saint-Louis, QC]

Mr. Speaker, I take special interest in federal policies, legislation, and the regulations that govern the pharmaceutical sector. The western part of Montreal, a great part of which falls in the riding of Lac-Saint-Louis, includes many brand-name pharmaceutical companies and medical equipment suppliers that together employ a great many of my constituents. As a result, I am fortunate to be regularly kept apprised of issues impacting this industry. Constituents also contact me to share their concerns about matters like the cost of drugs and drug safety.

Liberals support sending Bill C-17 to the health committee for review and improvement. Whether the government agrees to important amendments at committee will signal whether it truly takes the safety of Canadians with respect to pharmaceutical products seriously.

Incidentally, I applaud the member for Oakville who has been relentless in pressing for enhanced drug safety in Canada. I have been witness to his interventions at health committee and can attest to his tenacity and expertise on the issue.

Bill C-17 however is a delayed response to an issue that has demanded our focused attention going back to the very beginning of the Conservative government's mandate.

A key pillar in the national pharmaceutical strategy launched in 2004 was “Strengthening evaluation of real-world drug safety and effectiveness” to strengthen surveillance of prescription drugs.

An earlier attempt to address the issue, Bill C-51, languished on the order paper when the government, violating its own fixed date election law, triggered the 2008 election. That was six years ago. Canadians would like to know what has taken the government so long to address such a vital issue.

Let me get to the bill. What would Bill C-17 do? The bill applies to prescription and over-the-counter drugs, vaccines, gene therapies, and medical devices. The main features of Bill C-17 are as follows:

First, the bill would require mandatory reporting by health care institutions, presumably meaning hospitals, of adverse drug reactions in patients so that the government may know whether to re-evaluate a drug's safety.

Second, the bill would empower the government to order recalls of unsafe drugs without first entertaining representations from the manufacturer or being obliged to negotiate the recall with the manufacturer, provided the Minister of Health “believes that a therapeutic product presents a serious or imminent risk of injury to health...”. Astonishingly, the government does not already possess this authority when it comes to therapeutic products like drugs. On the other hand, the federal government currently has the power to recall bad toys, tools, cleaning supplies, clothing, and food, something it does with varying degrees of efficiency, but not unsafe drugs. Currently, drug recalls are at the discretion of the manufacturers and distributors. This is hard to believe but true.

Third, not only would Bill C-17 give the government the power to recall drugs, it would create stronger penalties for the marketing of unsafe pharmaceutical products, including jail time and new fines of up to $5 million per day instead of the current $5,000.

Fourth, the bill would authorize the Minister of Health to order a person to provide the minister with any information in the person's control regarding a therapeutic product that the minister believes “may present a serious risk of injury to human health” and that “the Minister believes is necessary to determine whether the product presents such a risk”.

Fifth, the bill would also authorize the Minister of Health to require label or packaging changes if the minister “believes that doing so is necessary to prevent injury to health...”.

Finally, the bill would allow the minister to order therapeutic authorization holders to conduct assessments and provide the results to the minister and in order to improve understanding about a product's effects on health and safety, compile information, conduct studies and tests, or monitor experience regarding a therapeutic product.

The bill is seen to have some important loopholes that compromise its ultimate effectiveness.

First, the definition of “therapeutic product” does not include a natural health product within the meaning of the National Health Products Regulations.

Furthermore, stakeholders are concerned about what constitutes a “prescribed health care institution” under the bill. Does this definition only mean hospitals or does it include clinics and doctors in family practice?

Also, the bill raises the real-life distinction between sellers of therapeutic products and holders of drug authorizations, underscoring the fact that in the complex modern marketplace, they may be different entities.

Incidentally, a therapeutic product authorization is:

....the authorization that permits the import, sale, advertisement, manufacture, preparation, preservation, packaging, labelling, storing and testing of a therapeutic product.

As an example of the distinction, and to quote an article in the Canadian Medical Association Journal:

...the company holding the market authorization may...license distribution to another company.

An historic example shows us why the distinction is significant and why there is a need for the bill to cover both sellers and those with authorization. When, in the 1960s, thalidomide was suspected of being harmful, manufacturers eventually withdrew the drug after some negotiation with Health Canada, the kind of negotiation this bill would presumably no longer require. However, free samples, the primary form of the drug's distribution, were still sitting in doctors' offices across the country. Health Canada did not have the legal authority to control or contain this problem.

The power the bill gives to the minister to recall or suspend drugs appears limited to sellers only. According to the CMA Journal, the health minister:

...should be explicitly empowered to issue suspensions and recalls to both types of “persons”.

Another issue related to the question of the federal government's capacity to fully protect Canadians from unsafe drugs has to do with whether it has the financial and human resources to ensure that drugs important to Canada are manufactured under strict quality control standards, along with ensuring quality control in manufacturing facilities in Canada.

We know that the government has been cutting in areas related to environmental protection and health protection, whether at the Canadian Food Inspection Agency or Health Canada. For example, budget 2012 cut 275 positions from the health products division at Health Canada, the group responsible for monitoring the safety and efficacy of prescription drugs.

Constituents have spoken and written to me because they have been concerned about conditions abroad in plants that manufacture drugs, often generics. Their concerns have often followed news of recalls of drugs such as Ranbaxy's atorvastatin calcium, the generic version of Pfizer's Lipitor.

For example, a 20 milligram tablet was recently found in a sealed bottle marked for 10 milligram tablets of the drug, resulting in a 64,000 bottle recall. This situation followed another episode, where glass particles were found in other batches of this same generic Lipitor.

As a result of such incidents, the U.S. FDA has apparently increased its presence abroad with a view to auditing certain facilities. What is Health Canada doing? Does it have the resources, financial and human, to do anything? Is it working with the FDA?

Whether in the U.S. or Canada, we need drug monitoring systems that catch problems before unsafe products are in consumers' hands and bodies.

This bill is obviously a good step in the right direction, but we have to ensure that any loopholes that would compromise its efficacy are closed. This can be done at the health committee. We also have to ensure that the government, quite apart from this bill, commits the funding necessary to guarantee that we have a safe drug system in Canada. It obviously has to work with the FDA and other international partners in the process of doing so.

Again, I congratulate the member for Oakville for his assiduous efforts in this area. I look forward to seeing what happens to the bill in committee.

[Hedy Fry, Liberal, Vancouver Centre, BC]

Mr. Speaker, I rise to support this bill, but to support sending it to committee. While this bill is a substantial improvement on the status quo, it has still taken the current government eight years, even though as Liberals we have pushed the government to change the way it regulates, the way it develops, and the way it looks at drug safety for Canadians.

However, the Conservatives have put the bill forward and there are some pieces of the bill that we like, but we think it falls short. There are other things we would like to see in this bill, and the minister herself has said in the House when she introduced the bill that she is open to amendments. So we are taking the minister at her word, and we are going to say we would like it to go to committee, and we hope the minister will be true to her word and will look at our amendments then.

Here are some things we like about the bill.

We think that the minister getting the power to recall drugs is a very important piece that has been a long time coming. The minister has to be able to do so without first getting the manufacturer's approval. Before this, the minister had to get the manufacturer's approval to recall a drug or to say that a drug has severe side effects. The new language says that “If the Minister believes that a therapeutic product may present a serious risk of injury to human health...”. That is good language, and we support the minister getting those powers.

The minister used to have to overcome the reluctance of the companies to want to give that information. Now the minister would have the ability to compel industry to provide the information about the drugs that the minister wishes to either seek a notice of compliance on or that are actually out there in the public, and be able to recall them. This is all common sense, but it is crucial because nobody but the company itself knows the background of the clinical trials, of how the company formulated the drug and how that innovation occurred. Therefore it is important that the company is made to be forthcoming with some of that information.

What we also like about this bill is that the minister would compel health care providers and pharmacists to mandatorially report at-risk drug reactions. As a physician, I can say that was a difficult thing to do because it meant that physicians, after a whole busy day of seeing patients, at the end of the day then had to report all these things. It can take sometimes two hours out of their day. Now that the minister would provide an electronic means by which this could be easily done, it would make it much easier for physicians to comply with this.

The minister's ability to enforce conditions on market authorization and to compel changes to product labels is also very important, and the ability to move that forward would ensure patient safety. We think that is important, but we also want the minister not to do so in a hurry so that it would stop due diligence in terms of the ability to get the kind of information we need.

The fines of up to $5 million a day for the failure to remove a drug or the failure to obey the enforcement measures by the minister is also a very positive area.

Members will notice that we are saying that there are some very positive things about this bill. However, before this bill came about, I was writing a bill on this very same thing because we got a little tired of waiting for the government to do this after eight years; so I had some round-table meetings with experts on the issue. Here are some of the major elements that these experts feel are missing from the bill, which would make the bill stronger: better implementation of the ability to ensure patient safety, to ensure that there are appropriate regulations, and to ensure pre- and post-market surveillance of drugs.

This is about the precautionary principle, which should give the minister the power to ensure that the first and foremost thing she or he is concerned about, wherever possible, is being sure that on reasonable grounds, to prevent potential injury to a person or a citizen, the minister has that power to recall or remove a drug or not allow for notice of compliance. “Reasonable grounds” is sufficient. The minister should be protected for her ability to do this, using the term “reasonable grounds”. The minister's power should not just be limited to those who sell the drugs, because we know that in some areas the people who manufacture the drugs are not the people who sell the drugs.

They have different production arms and different distribution arms that distribute their drugs under different names. Therefore, it is important for the minister to look at the whole chain of distribution not merely at the manufacturer when recalling a drug.

Right now I think that the definitive issue of injury or harm is up for interpretation. For instance, let us look at the birth control drugs that did not work recently. No one felt that this was an important reason not to allow the drug a notice of compliance or to recall it, because they felt that if women became pregnant when using a contraceptive that did not work, it was not an adverse reaction and it did not cause severe injury or harm, because pregnancy is a lifestyle choice. I think that was a bending of the interpretation of what harm is. If women are taking a contraceptive, it is because they do not want to get pregnant. If they get pregnant, that is an adverse reaction. I think the ability to define what is injury or harm should be more clearly spelled out for two reasons: one, to protect the patient; and, two, to protect the minister from any kind of reaction from the company because it is clear what she means and what the legislation means by injury or harm. That should be clearly spelled out. It should be based not on subjective but on objective criteria that are in keeping with what we know about risks and harms pertaining to drugs. That would provide the minister protection and give her broader powers.

As well, we know that we cannot tell the adverse effects of a drug purely from the clinical trials. When a drug is undergoing clinical trials, it is done with a cohort of people who have been chosen, and out of that cohort it can be decided what the negative and adverse reactions are to the drug. However, when the drug goes out into the main community, into the citizenry at large and the general public, individual reactions to drugs can differ. While people may not have had reactions during the clinical trial, others in the main community may show adverse reactions. Therefore, the minister must have the ability to say that, although the government gave the drug a notice of compliance, due to the new reporting requirements for physicians and pharmacists it has noticed that after a year or six months there are adverse reactions that were not intended and did not show up in the clinical trials and that the drug will be recalled temporarily while we check on these. Then, ensuring that the precautionary principle is in place, the government can look at the drug and either put it back on the market if changes have been made or permanently recall it before it does any further harm.

To clearly define what we are doing is in the best interests of the minister. It would protect her from any kind of legal suit and so forth. That is an important piece we would like to see included.

The Auditor General has spoken on many an occasion about the lack of transparency in Health Canada's decision-making process. For instance, Health Canada publishes only very limited information on drugs and high-risk medical devices for which a notice of compliance is applied for. However, it does not tell us why it did not allow a drug a notice of compliance. It does not tell us what its opinions are about the drug, even though it may give it a notice of compliance and say that it is generally safe. There may be other clinicians who have said there are some concerns about the drug. Health Canada should put that out there to the public, so that pharmacists, prescribers, and patients would know that there could be some conditions under which the drug was allowed to go out there. There may be some potential negative effects with which the minister and the department are concerned, but they are releasing the drug anyway. That was in the bill when it was put forward as Bill C-51. I noticed it has been removed. I wonder why, because it was a very good piece in that legislation that we agreed on and that the Auditor General wanted to happen. That enhances the transparency of Health Canada in terms of its regulations and looking at drug safety.

We cannot afford to use the fact that the manufacturer does not want us to give out trade secrets. We do not have to give out trade secrets when we are saying that we think there may or may not be a problem that we have in the back of our mind even though we have put the drug out there. It is an important thing to do. Europe is doing it. The European drug agency is putting out what the negative opinions are on a particular drug, even though it felt that the benefits outweighed the risks and that is why it put it forward.

There should be a legal requirement to register clinical trial data. This should be open to physicians, patients, and pharmacists so that they are able to know what clinical trial data shows. Now, I know that the government thinks that would let out trade secrets. However, the European drug agency is doing this.

The clinical data that is put out in terms of the clinical trial does not have to disclose proprietary issues regarding the drug itself or its trade secrets. It is about the ability to ensure patient safety, which is foremost in the mind of Health Canada, as it should be. Therefore, to release the full report of pre- and post-clinical trials and surveillance on an ongoing basis is an absolute necessity, but it is not in the bill. Not only is the European drug agency doing this, it is thinking of expanding it to bring in anonymous or non-nominal general patient responses to the drugs so that, again, there is full knowledge and full disclosure. Also, the FDA has just tabled its intention of doing the same thing.

Canada is way behind both Europe and the United States in terms of looking at patient safety, in terms of full disclosure, and in terms of acquiring full disclosure by the manufacturers, who do not seem to be worried about the proprietary issues of trade secrets because they know what to put in and what not to. Clinical information is not a proprietary trade secret. The formula of the drug and how the innovation occurred are proprietary trade secrets, but not clinical trials or data about them.

It is important for the minister to strengthen the bill by doing this and to do everything under the rubric of good independent research, and not just the companies' research. There should be an independent body that looks at those clinical trials, and not just Health Canada. Again, Europe is doing that, and the FDA has tabled its intention to do that. It has to be done in the name of public safety and good evidence-based information.

We would like to see more transparency from Health Canada on why it gives a drug a notice of compliance and why it does not. What are the reasons? Again, we need to know that about certain drugs. People read about drugs, and when they find out that other countries use certain drugs, they wonder why Canadians cannot get it. They want to know why they are not allowed access to drugs that could save their lives, et cetera.

Good information helps people understand why certain decisions are made. However, right now we do not know anything about why Health Canada approves a particular drug or not, why certain drugs are suspended, and why some drugs remain on the market in spite of adverse reactions in other countries. These are some things that we feel would strengthen the bill.

Disclosure in the name of public safety is always very good. We need to ensure that the first thing in the mind of Health Canada when it approves a drug, or not, is that people can trust Health Canada to make good decisions in their best interest, and be able to do so in an objective and clinical evidence-based response. I think that right now Health Canada faces a great deal of mistrust from the public and drug prescribers because it is not transparent in some of these things.

Why would the bill allow government and cabinet to impose stringent rules favouring data protection of manufacturers under the Food and Drugs Act? We do not think that should be able to stand alone.

We have seen issues where people have asked for drugs, but the government has said that the Food and Drugs Act is the reason it is not doing certain things. However, the Supreme Court of Canada has ruled very clearly that the issues of right to life, liberty, and the security of the person trump any piece of legislation, which is under section 7 of the charter. Patient safety should be foremost in anything that the bill would bring forward.

We oppose the amendment to the Food and Drugs Act in the bill to protect manufacturers' data. It should only be for proprietary data protection and not for anything else. The government should be protecting the patient, and Canadians.

The Liberal Party thinks that the bill is long overdue. There are some good points in Bill C-17 that move forward, with some steps we approve of, to enhance patient safety and knowledge of drugs for therapeutic prescribers.

The minister said that the bill should be open to amendments. We have, as I said just now, about five amendments we would like to see that would strengthen the bill. We approve of big chunks of the bill, and we would like to see the bill go to committee. We hope that the minister will be true to her word and allow for amendments to come forward so that the bill can go to the House and be accepted by all of us unanimously, because it is in the best interest of patient safety.

Food and Drugs Act

[Patricia Davidson, Conservative, 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.

[Glenda Yeates]

Thank you for the question.

My understanding is that in 2004 there was a recommendation from the committee, and in fact, the department took a number of steps at that time. It had some expert witnesses, I understand. It looked into the question of what was feasible, and what was reasonable in terms of clinical trials.

As was noted, for example, there was a bill that was introduced at that point, Bill C-51, which addressed some of that, so a lot of energy went into understanding whether we should do things as part of the legislation. When that legislation did not go forward, the department made a number of changes. It increased the transparency by focusing.... It actually encouraged, as we write a letter to a clinical trial site, that we ask them to put their posting on one of the WHO international sites. So we have a number of clinical trials that are now doing that.

[Paul Glover]

Mr. Chair, I thank the member for her question.

It's true that our powers are somewhat limited with respect to our ability to request a change on…

the monograph, the labels. We do have limited powers to demand or impose label updates on products as we see them. We end up working in collaboration with the companies in order to negotiate the sorts of changes we would like to see.

The process to obtain an update on instructions for a drug is now being negotiated with the industry.

We find that this works for us. Obviously we exert a fair amount of influence over industry to comply with our requests.

We have the power, if we feel that industry is not complying, to simply issue a warning saying we've asked the industry to do x and they've declined. Oftentimes that's enough to have industry come into compliance with our recommendations. We do have powers beyond just the negotiation.

In Bill C-51, a previous piece of legislation, there were some proposals that would have allowed us to go beyond simply working in a collaborative nature with industry, to one that would be imposing our direction upon them. Given what happened with that piece of legislation, we are taking a look at what other steps we can take to ensure the regulatory framework we have allows us to move as quickly as possible.

The one problem I would acknowledge with the current process is that it does take a bit of time in terms of negotiating rather than simply directing.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Mr. Speaker, this is an issue I brought forward in 2007. It was a private member's motion that was supported unanimously by the House. It was not only supported by the House, it was also supported by the government and Health Canada. That motion was put into Bill C-51 that was before the House. If it had not been for the fact that the bill died on the order paper because of an election, this would already be in legislation.

The government does support it. It has tried to bring it forward. It is not a case of the government not supporting it, or being negligent by not doing this. There has been support all the way through on this bill and on this issue from Health Canada and the government.

[Patricia Davidson, Conservative, 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.

Seeds Regulation Act

[Chris Charlton, NDP, Hamilton Mountain, ON]

Mr. Speaker, I am delighted to rise in the House this evening to participate in the debate on Bill C-474, An Act respecting the Seeds Regulations (analysis of potential harm), which was brought forward by my NDP colleague, the member for British Columbia Southern Interior.

I will be the first to admit that as a member of Parliament from Hamilton, which is nationally known as Steeltown, I am more familiar with the manufacturing sector than I am with the agricultural sector. It was not that long ago that over half of my riding was in fact prime agricultural land, with successful family farms like the Youngs, the Bethunes, the Ryckmans, the Burkholders and the Marshalls, to name but a few. Sadly, as Joni Mitchell would scold us, we paved paradise and put up a parking lot.

That is simply to say that many of the people in my riding of Hamilton Mountain may be urbanites, but they feel a deep, personal connection to agriculture and bring those values to bear in thinking about Canada's future.

Similarly, we have a thriving environmental movement in Hamilton that led the “eat local” campaign in our community, and has done much to raise awareness of organic foods and, more generally, healthy eating.

Also, a great many Hamiltonians are keenly interested in food and product safety, as well as proper labelling. I do not think there is single piece of legislation outside of the Conservative government's reviled decision to impose the HST on Ontarians that generated more petitions, letters or phone calls than Bill C-51, which sought to amend the Food and Drugs Act in the last Parliament. That bill purported to modernize our food and drug provisions bringing us into the 21st century and bringing our rules and our regulations in line with modern day science. It did not take too long for Canadians to figure out that this was a ruse. It was an attempt to make Canadians believe the government would be on their side when in fact it was loosening its regulatory control.

What Canadians wanted was legislation that operated on the basis of the do no harm principle, the precautionary principle, which means that we do not allow products on the market unless there is evidence that they are safe beyond a reasonable doubt. Unfortunately, this is not the risk management model that we saw with the Liberals before and with the Conservatives today.

There is a marked difference between the do no harm principle and the risk management model. Do no harm means that we put people and safety first. The risk management model means that we can only go so far in ensuring the safety of Canadians so we will allow the products on the market, cross our fingers and then see what happens. It will be up to individual Canadians to determine whether it is worth taking the risk. It will be up to the corporations that produce the products to regulate themselves and decide if they are in line with the standards on paper.

The risk management model is not a proactive regulatory model that puts the needs and concerns of Canadians first. It is a model that puts the needs of big pharma, large corporations and global capital forces ahead of ordinary citizens. It is a model that makes guinea pigs out of Canadians.

We have had our share of offering up people as guinea pigs for large corporations. I do not need to remind people who may be watching us on TV right now about the incidents in our past, especially when women were treated as guinea pigs. Thalidomide and breast implants are just two of the examples that come to mind right away.

What does that have to do with the bill that we are debating today? It is relevant for two reasons.

First, it is because many of the people who were concerned about Bill C-51, and in particular about its impact on natural health products, are also deeply concerned about the issues related to the genetic engineering of our food supply. They have strong views on Frankenfoods and they understand the importance of ensuring that a robust framework is put in place when it comes to genetically modified organisms or GMOs.

Frankly, at the moment Canada's framework is inadequate. Canada is currently the fifth largest producer of genetically modified crops in the world, after the United States, Brazil, Argentina and India.

Canada could learn a lot from Argentina. It has legislation which ensures that the release of GMOs first requires an assessment of the safety of food and livestock feed, of the bio-security of the environment and an assessment confirming that its exports will not be negatively impacted. In Argentina, therefore, the analysis of the impact on exports in the GMO approval process is an integral part of the analysis that determines whether the sale of any new genetically engineered seed is permitted. In Canada, that is not currently the case and Canadian farmers are suffering the consequences.

It is this deficiency that Bill C-474 seeks to redress.

However, as I said earlier, there is also a second reason why this issue is being followed so closely by many of the same people who were engaged in the debate around Bill C-51, and that is because Bill C-474 also pits a tenacious advocate who represents hundreds of thousands of Canadians against an entire industry. It is David versus Goliath. In this case, David is the member for British Columbia Southern Interior who is battling the Goliath of the Monsantos of this world. There is absolutely no doubt that the hope of the biotech industry is that over time the market is flooded with genetically-modified organisms and that at that point there will be nothing anyone could do about it except quietly surrender. In fact, that is exactly what Don Westfall, the vice-president of Promar International and a biotech consultant, was quoted as saying in the Toronto Star in January 2001.

However, the member for British Columbia Southern Interior is not about to surrender and neither are his colleagues in the NDP. We understand what a disastrous impact the absence of an analysis of potential harm would have on Canadian farmers and therefore on Canadians as a whole.

We have long been convinced that big biotech companies, such as Monsanto, have been running a scam with regard to their genetically-engineered crops. Despite 15 years of failed promises to feed the world's hungry and, more recent, to save humankind from climate change, the Canadian and U.S. governments inexplicably continue to write all the rules completely in big biotech's favour. As was recently revealed in WikiLeaks cables, U.S. ambassadors were even going so far as to advise Washington to start military-style trade wars against any European country that dare stood in opposition to GE crops.

Despite lengthy court challenges which, for a time, kept the decision at bay, the USDA has just authorized the nationwide and unrestricted commercial release of Monsanto's genetically-engineered seed. After acknowledging that GE alfalfa poses many risks to organic and conventional farmers, USDA secretary Tom Vilsack, whose ties to Monsanto are well known, has just imposed the impossible burden of keeping alfalfa seed free from GE contamination entirely on farmers. The Center for Food Safety in the U.S. has already announced that it will again challenge this decision in another round of expensive court action.

One way or another, and regardless of the imminent threat this poses to all farmers, especially to our lucrative domestic and export organic markets, it is only a matter of time before U.S. Roundup Ready Alfalfa will be found contaminating our fields in Canada.

The silence from the Canadian government has been deafening. Monsanto could decide to go ahead and register its GE varieties in Canada, as it has already been awarded the necessary health and environmental approvals by the current government.

It was in order to prevent that very scenario that my colleague, the member for British Columbia Southern Interior, moved forward with Bill C-474. His bill would require that the government conduct an analysis of potential harm to our export markets prior to approving new genetically-engineered seeds.

The Conservative Party has sided completely with Monsanto and the rest of the biotech industry since the debate first began. Although the Liberals initially supported our bill, they have since succumbed to pressure from the biotech lobbyists and now say they, too, will vote against it at the final reading. I know, another flip-flop from the Liberals is hardly even worth noticing any more.

However, just as it is in the States, the one-sided mantra from both of these parties is now to preach coexistence with non-GE farmers and to keep Canada's regulations science-based and entirely free of any political or market considerations.

What did witnesses actually say when they testified about Bill C-474 in front of the Standing Committee on Agriculture and Agri-Food?

Let me just quote Kurt Shmon, president of Imperial Seed. He said:

Canada's science-based approach works very well for the domestic marketers of seed, the Monsantos, the Syngentas, and the Bayer CropSciences, but what does it do for the producer? This approach does not take into consideration what the producers want, nor does it address what the market wants. These are the two most important issues and they are absent from the registration process.

That powerful theme was then reiterated by several other presenters to the committee, yet both the Conservative government and the Liberals are wilfully ignoring it.

We cannot just ignore what is happening to farmers in our country. Farmers feed cities, and that is more than just a catchy slogan. It underscores an important reality that is crucial to our economic future.

Yes, we need to acknowledge advances in science. However, we must also acknowledge the economic reality of farmers.

In short, we must pass Bill C-474. Let us do it now.