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.

[Blake Johnston]

On your first point, Canada has some of the most progressive food labelling rules in the world. The nutrition facts panel we have on food in Canada is only very recent; it came into place just a few years ago, and the rest of the world looks at it.

The health committee was looking at food labelling under their child obesity study not too long ago. They were looking at the United Kingdom and a stoplight or traffic light front-of-package label. During their review, they realized that the reason the British have this is that they don't have the nutrition facts panel we have in Canada, which gives the recommended daily percentage of intake of all the ingredients that are important.

I would say that on the issue of nutrition, Canada is a standard-bearer in terms of the information it provides consumers. That was really carefully tested, and it's in place for the vast majority of food products.

Concerning the subsection of the food group you raised, there were some logistical difficulties with some meat categories, and I believe some vegetable categories as well don't have the nutrition facts panel. I think at the time the government decided, or there was some consensus at that point, that the logistical difficulties of putting those on certain items—how do you put it on a head of broccoli, if you will—presented enough problems that they didn't do it at that stage. But the vast majority of products in the grocery store have that facts panel, which make us a world leader.

On your second point, there are two different issues: we're talking about nutrition labelling versus origin. They're very important to differentiate.

In my opinion, Health Canada is very good at what they're telling consumers about food on food labelling, and it's very carefully managed. They don't do anything half-cocked. They do efficacy studies on everything they do to make sure it's interpreted properly by the consumer, and it's very evidence-based and very good.

I think we really have to separate the two and see the difference between that and what we're talking about here, between the labelling of products as to origin and the labelling around nutrition and health and safety.

Concerning all imports playing by the same rule, that's something we've supported very much, mostly in the context recently of Bill C-51, which is the legislation the government has tabled to amend the Food and Drugs Act in relation to the import safety issue.

We're firm believers that imported products and importers need to comply with all the same rules as domestic producers and that the food industry needs to essentially own their value chain and be accountable for things they bring into the country. I think this legislation accounts for that by requiring importers to register with the federal government and be a bit more accountable than perhaps they are now.

On your final point, about misleading statements, I'm not certain about the administrative monetary penalties that are open to CFIA, but the Food and Drugs Act is a criminal statute, so it's my understanding that companies that are seen to be making these mistakes are open to criminal prosecution in some instances and fines in others.

Perhaps Joe could correct me on that one, if that's—

Food and Drugs Act

[Joy Smith, Conservative, Kildonan—St. Paul, MB]

Mr. Speaker, I am grateful for the opportunity to speak to Bill C-51, an act proposing amendments to the Food and Drugs Act.

First, this proposed legislation is but one element of our government's action for meeting an important commitment.

In October's throne speech we committed to taking action on food and product safety to ensure Canadians had confidence in the quality and safety of what they buy.

Following this, the Prime Minister announced the food and consumer safety action plan last December. This is a comprehensive plan with the goal of modernizing and strengthening Canada's safety system for food, health and consumer products.

In February, budget 2008 invested $113 million for two years to support the plan in meeting its purpose. Now we are taking the next steps by introducing important legislation.

Along with introducing the proposed new Canada consumer product safety act, we have also brought in Bill C-51 to amend the Food and Drugs Act. Taken together, these two complementary pieces of proposed legislation include measures that will further protect the health and safety of Canadians, and this bill is all about that.

They propose to do this by stressing: first, active prevention to stop as many problems as possible before they occur, second, targeted oversight so the government can keep a closer watch over products that pose a higher risk to health and safety; and third, rapid response so we can take action more quickly and effectively to problems that do occur.

I want to begin by noting upfront that despite the need to update it, how durable our Food and Drugs Act has been over many years. Let me provide a bit of history.

Although certain food laws were in place before Confederation, the first federal legislation dealing with the issue of food safety was enacted in 1874. It is interesting to note that the United States did not pass similar legislation until 1906.

Canada's 1874 law did not receive its main impetus from adulterated food. What apparently forced the legislation were the large quantities of grossly adulterated liquor being consumed. Parliament was besieged with requests to do something about the situation. Hence in January 1875 an Act to Prevent the Adulteration of Food, Drink and Drugs came into effect. In 1920, just in time for America's prohibition act and the roaring 20's, it was superseded by our Food and Drugs Act.

That the world has changed since the 1920s is certainly an understatement. In fact, it has changed a great deal since the 1950s when the act was last updated. While the act has proven resilient, it is now 50 years old and definitely in need of updating.

Our foods and health products now come from the four corners of the earth. Moreover, new technologies and production practices have radically changed the industry. It is also the case that consumers today are more health conscious and have higher expectations about the food and drugs they purchase.

While on the whole food quality has increased, incidents of contamination are by no means rare. Furthermore, production and technological advances have created new risks and challenges for food inspection and oversight mechanisms.

Today, however, modernizing our food safety system means adopting a more integrated and proactive approach. Moreover, any improvements made today should lead to more extensive information on food and drug risks being provided to the Canadian public. They should involve the food industry and the consumer as well as government in addressing risk. This only makes for greater safety. The proposed amendments should help streamline and provide more consistent regulatory mechanisms across all sectors.

Bill C-51 would do all of these things and more, and I will elaborate.

The government's proposed amendments will make the Food and Drugs Act much more proactive. Let us look, for example, at the amendments in the bill, focusing on the food regulatory system. They will permit us to focus on identifying where potential risks may be introduced in the food system and on taking more active steps to prevent food safety issues. Moreover, the amended act would extend its coverage prior to the point where food is actually sold. In fact, the amended act would apply to food from the moment it arrived in Canada to the point of sale. With these—

[Paul Szabo, Liberal, Mississauga South, ON]

Mr. Speaker, we have just started debating this bill and I have received many emails from constituents and organizations that represent natural health products.

Because Bill C-51 would amend the Food and Drugs Act, and one really has to look at the Food and Drugs Act while looking through the bill, I want to raise just one of the concerns, which is that many natural health products that have been sold in Canada for decades would become unavailable and remaining products would cost much more under clauses 13 and 18.7 of the bill.

Clause 8 replaces sections 17 to 21 of the act, but clause 13 states:

No person shall conduct a controlled activity unless they are authorized by an establishment licence to do so.

It creates now, I believe, a licensing requirement. I do not see the details on licensing. I assume that licensing is either included under the Food and Drugs Act, in the appendices or regulations, but the member will appreciate when someone makes that assertion, there must be an answer. If the allegation is that these products will not be available because they will require a licence, and the provisions of getting a licence may be so onerous, lengthy or specific, that it may in fact result in there not being the availability of certain natural health products.

I wonder if the parliamentary secretary is aware of that issue and whether he can provide an answer to the concerns of those who rely on these products.

[Steven Fletcher, Conservative, Parliamentary Secretary for Health]

I want to assure you, Mr. Speaker, that when I was referring to the loony left, I was only referring to the members I sit beside on my right. I note that you are not one of those members, Mr. Speaker.

Canadians want their government to do the best job possible to ensure the safety of foods, health and consumer products. We committed to meeting this expectation in the Speech from the Throne. The bill that we are now debating is an important part of meeting that commitment. It is a major component of the food and consumer safety action plan, which the Prime Minister announced in December.

The plan seeks to modernize and strengthen our food, consumer and health products safety system. It is a plan that is now supported by a two year funding commitment of $113 million, announced in budget 2008. It is a plan which shows that the government is taking product safety seriously and is taking action.

Our plan takes a new approach to food and product safety, based on active prevention to stop as many problems as possible before they occur, targeted oversight so the government can keep a closer watch over the products that pose a higher risk to health and safety, and a rapid response so that we can take action more quickly and effectively to the problems that do occur.

Mr. Speaker, I will be splitting my time with the member for Kildonan—St. Paul.

The next step in the plan is updating our product safety legislation. As a result, Bill C-51, An Act to amend the Food and Drugs Act , is now before the House. It has become very clear to the government that the Food and Drugs Act needs to be modernized. The act is now more than 50 years old and it has simply not kept pace with modern expectations or standards.

Given the significance of the task, our effort has required discussions with stakeholders. We have heard that it is not good enough for our laws to focus largely on one stage in the health products life cycle. Yes, it certainly makes sense to assess health products carefully before they reach market, and today we are doing that vigorously. Bill C-51 does not propose to change that.

Instead, it seeks tools to conduct ongoing assessments of risks and benefits, even after the product is in use by Canadians. Instead of only focusing on products before they reach Canadians, we want to require companies to provide information throughout a health products' full life cycle.

Under the bill, and every step of the way, we will be able to ask whether a product's risks outweigh the benefits. This means that consumers and health professionals will have access to more and better information. They will be able to make better informed decisions about the safety and the use of the products.

Second, it seeks to anchor the safety planning in law. The reality is that the vast majority of companies already do plan for safety. They know it is just good, responsible business to do so, and with more information made available, it will be possible to update plans for improving safety to reflect new data or emerging concerns.

With Bill C-51, the government will have greater information. With greater knowledge we can work with companies and health professionals to better protect the safety of all Canadians.

With provisions that support greater openness and transparency in the regulatory system, Canadians can access the information they need about a product, the risks and the benefits, to ensure that they are making informed choices for themselves and their families.

We can use greater knowledge to target our oversight and we can use it to learn about problems as early as possible to respond more rapidly to better safeguard the health of Canadians.

This bill also accounts for the fact that today we receive many products from abroad. As a result, it would provide for modern inspection authorities and new strategies to oversee the safety of imported products. This focus on prevention is critical. Our focus on information is also essential to supporting rapid responses by the government when problems do occur.

Through Bill C-51 we are seeking the power to order a recall of a product that poses a safety threat. I want to mention one example of safety risks, what experts call “adverse drug reactions”. That is the health system term for people reacting negatively to a drug.

Under Bill C-51 we are seeking the authority to work with the provinces and territories to enhance the reporting of adverse drug reactions from hospitals. This would go a long way in helping detect safety problems earlier and the sooner we know, the more rapidly we can respond and better protect Canadians from unsafe health products.

I do not want to suggest that the modernization of the Food and Drugs Act will mean a night and day kind of change for most health products or companies. They do a good and reasonable job now. The vast majority of industry takes consumer safety very seriously. It is only a small percentage that acts irresponsibly and this is who we seek to protect Canadians from. In the process, we will allow law-abiding Canadian businesses to compete on a more level playing field and we will also target those who act irresponsibly with steep penalties.

Today, a serious incident under the Food and Drugs Act can just receive a $5,000 fine. Under Bill C-51, we are seeking to raise that up to $5 million because the health of Canadians is worth it.

The Government of Canada is taking consumer safety seriously and taking action. Many partners across the health system share our commitment to this direction, including consumer representatives. We believe all parties should support the direction set out in Bill C-51. I urge all of my colleagues on both sides of the House to support Bill C-51, so we can modernize the health and food product safety for Canadians.

We have all listened to the debate today and the health committee will have another opportunity to listen. The government will listen and, there is no doubt about it, the government will act to protect the health and safety of all Canadians.

[Larry Bagnell, Liberal, Yukon, YT]

Mr. Speaker, another one upon whom the Conservatives could have cast aspersions is one of my constituents who asked questions. I wanted to ask the government, but it is not putting up any speakers, just the minister who introduced the bill, so I cannot ask the questions. Maybe the member could answer just three concerns that this constituent put forward.

Will this new law be used to abuse and punish special interest groups, minorities, religious groups or others? Why do the bureaucrats want seizure warrants without judge approval? With fines being increased a thousand times and seizing authority without a warrant, is Bill C-51 meant to bankrupt and silence its target audience?

[Judy Wasylycia-Leis, NDP, Winnipeg North, MB]

Mr. Speaker, I am pleased to join in the first round of debate on Bill C-51, a bill to amend, in large measure, the Food and Drugs Act.

I bring to this debate a lot of skepticism but it is a healthy dose of skepticism based on the history of this whole aspect of Health Canada and our regulatory regime in Canada.

It will be no surprise to the House to learn that this is the fifth attempt by government in the last decade to overhaul the Food and Drugs Act. Four times before the Liberals attempted to do so and each time they failed. Why? They failed because the community spoke up and demanded more accountability from government and much clearer answers around accountability and regulatory authority.

Members will recall Bill C-80, a draft piece of legislation that was supposed to do much of what we have before us today. That bill was supposedly attempting to modernize our food and drug provisions, bring us into the 21st century and bring our rules and our regulations in line with modern day science.

It did not take too long for Canadians to quickly figure out that this was a ruse. It was an attempt to make Canadians believe the government would be on their side but was in fact loosening its hold over regulations, minimizing its role and moving us away from what has been an entrenched part of our history, and that is a bill that regulates the safety of food and drugs in such a serious manner that it is part of the Criminal Code.

That legislation 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. That is the do no harm principle. It is not the buyer beware principle. It is not the risk management model that we have seen 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 Canadians' safety so we will allow the products on the market and then we will see what happens. It will be up to individual Canadians to determine whether or not 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 pharmaceutical corporations. I do not need to tell the House about the incidents in our past, especially when women were treated as guinea pigs. Thalidomide comes to mind as does Depo-Provera, breast implants and the list goes on.

We need to ask ourselves some questions. If we cut through all the rhetoric and tough talk about putting safety first and modernizing our system, are we better off? Are we any closer to the kind of system that Canadians thought we had and expected to have, which was abandoned by the Liberals?

It was abandoned when, in 1997, the former minister of health, Allan Rock, in his first gesture as minister of health, killed the federal drug laboratory, the only independent federal research lab in this country for testing on a post-market surveillance basis. It tested whether drugs that were on the market were safe and whether there were any negative consequences when that drug was combined with certain foods, other drugs or natural health products. It was a lab that performed a very important safety function in our country.

That was the beginning of a whole string of actions taken by the then minister of health, Allan Rock, and subsequent Liberal ministers of health to dismantle our regulatory system and move us away from the do no harm model toward a system where corporations pay for their drug approval processes. The bulk of the fees for our drug approval process comes from the corporations themselves.

Scientists at Health Canada have seen numerous incidents and they said that enough was enough. I think of Dr. Michèle Brill-Edwards who spoke up about being cornered to approve something she thought was not safe. She had to leave Health Canada to have any sense of integrity intact.

There were many others. Who can forget the whole group of veterinary scientists who stood tall about the tampering with food products and the adulteration and modification of veterinarian drugs? They were chastised, disciplined and lambasted by the Liberal government.

Whatever happened to the government being a bastion of independent, objective science that operated on the basis of the constituents it is supposed to serve? Whatever happened to government for the people, by the people and of the people? Nowhere is this more important than when it comes to the food we eat, the drugs we take because of medical conditions and the water we drink to sustain us and yet in those areas the government has abandoned us in large measure.

Today we are supposed to believe that the Conservative Government of Canada has such integrity, courage and vision that it is offering us a blueprint for a do no harm precautionary model around drugs and food. I bring to this debate a dose of healthy skepticism because I have seen nothing from the Conservatives to date that leads me to believe that the government is on the side of ordinary Canadian families and is not on the side, first and foremost, of the big corporations and their profit margins.

I have not seen that when it comes to housing, education, health care, women's equality, people with disabilities, the environment, jobs and child care. I have not yet seen the government stand up for Canadians

[Steven Fletcher, Conservative, Parliamentary Secretary for Health]

Mr. Speaker, I assure the member that there are no shortcuts when it comes to clinical trials. In fact, the bill, through the life cycle approach, is much more effective in ensuring the safety of Canadians because it would allow the government to monitor the products after they reach the market.

I will also address a concern raised by the Bloc. Proactive measures have been taken by the minister and the government. It has been demonstrated with the presentation of Bills C-51 and C-52. It has been demonstrated again in budget 2008 in which $113 million has been invested to ensure that we will have a food and consumer safety action plan that is well funded.

Will the member agree that a life cycle approach is the right way to go and that it is important for the Minister of Health to have the ability, in rare but extreme cases, to remove a product off the shelf? Those are really the main points of the bill. I hope the member will be open to accepting that the government is on the right track without predetermining, what is so often the case, negativity.

Does the member agree with the life cycle approach and mandatory recall, if necessary?

[Christiane Gagnon, Bloc, Québec, QC]

Mr. Speaker, I am pleased to speak to second reading stage of Bill C-51 to amend the Food and Drugs Act. We know this act has been around for 40 years and that not too many changes have been made to it with respect to food and drug safety.

Bill C-51 bears a strong resemblance and is closely related to Bill C-52, which seeks to better monitor products on the market and reassure the public about product safety.

Here the government is taking things a bit further. It wants to cover other products, including pharmacological products, and look at pharmacovigilance.

Why does the government want to modernize this act? Because the public is quite worried. In the past few months and years, it has come to our attention that some products are harmful to our health. Certain drugs have adverse effects causing death.

For example, there is Singulair produced by Merck Frosst. This is an asthma drug that causes suicidal ideation. Champix, an anti-smoking drug produced by Pfizer, also causes suicidal ideation and depression. What is more, anti-psychotic drugs for children apparently cause obesity. These are some of the harmful effects of taking those drugs.

More and more people are worried about some of the drugs on the market. Some consumer products, such as children's toys or toothpaste from South Africa, also contain toxic substances. Other products contain mercury. The government is introducing this bill, which it was asked to do, to reassure the public about drug safety.

The minister has been asked about this a number of times. In 2006, the Auditor General issued a scathing report saying the government should make some changes. The lack of control by the Canadian Food Inspection Agency was among the Auditor General's many criticisms. Even that agency admits that unsafe products may be found on the shelves and that the public has cause for concern.

Will the bill properly respond to this situation and ensure food and drug safety?

The minister probably wants to reassure citizens with his bill. The purpose of Bill C-52 is to increase the industry's accountability with regard to the food supply. The government may also require that food safety monitoring be implemented. To that end, it gives the minister the authority to conduct inspections at any time. It will also require the industry to report the adverse effects of consuming certain foods. It also provides for a tracing system not just for foods but also for cosmetics and therapeutic products.

Is this the right approach? The objectives are laudable. How will it be done? We know that a whole set of regulations will come after the bill. However, today, we cannot discuss the regulations because they are not available. We hope that they will be provided when the bill is studied in committee. With regard to the Assisted Human Reproduction Act, passed in 2004, only one regulation was submitted to committee review and we are still waiting for the regulations. We hope that the regulations will follow on the heels of the bill so that they may be debated in committee.

Will the government meet the expectations of Canadians?

In response to the fears surrounding the safety of food and therapeutic products, the Auditor General was headed in the right direction when she sounded the alarm for the government by asking it to increase human resources and particularly to provide funding for inspections.

We need only think of natural products, for example. We know that there are between 33,000 and 40,000 products waiting for inspection in order to be licensed because of the shortage of inspectors. This applies not just to natural products but in particular to foods and consumer products. The inspectors quite often do not have the requisite training to properly inspect all these products.

There was a call for better training for staff and better human resources. I am afraid that this objective is not met by this bill. We can see that resources are lacking, as I was saying. Concerns about these shortcomings were expressed not only by the Auditor General but also by the Canadian Food Inspection Agency.

Today, Bill C-51 goes one step further. In committee, we are studying aspects of post-market monitoring and pharmacovigilance. Over the past few months, we have met with experts and witnesses. We would have hoped to see Bill C-51 drafted along the lines that the committee suggested to the minister after it received recommendations from experts. However, he got a little ahead of the committee's work, and there was some duplication.

We are now considering this bill at second reading. We will vote in favour of the bill because we want it to be referred to committee for further study. That means that we will have to invite the same number of people, the same experts, to come tell us what they think about this bill. We would have hoped that the minister would have waited for our amendments and recommendations.

That is not what happened, so we hope that the minister will be open to some amendments to the bill in areas where he did not take into account all the concerns of the witnesses who appeared before the committee. We hope that the government will be open to these amendments. I am sure that amendments will be proposed, because the bill does not adequately address the issue of food and therapeutic product safety.

I would also like to talk about adverse drug reactions, which the bill addresses. Various experts commented on this and clarified things for us. That is what we would have liked to pass on to the minister before this bill was introduced. For example, consider hospitals' obligation to report on adverse drug effects, as set out in the bill. Many witnesses told us that that might not be the best way to go. Currently, between 1% and 10% of adverse effects are reported. Is the government hoping that by introducing this measure, that incidence will go up? Probably.

We would like to see greater interest in the reporting of adverse effects, but not just any old way. Some witnesses told us that hospitals may not have appropriate structures in place to fulfill this obligation. It might be too much red tape.

I do not know what kind of clarification the minister will provide on this issue. Regardless, we would have hoped to have had an opportunity to submit our recommendations after analyzing all of the testimony.

As I was saying, the bill also seeks to create a register of adverse reations.

We wonder about the reporting of serious and rare adverse reactions, but especially about how this information will be passed on so that health professionals are kept abreast of information from the adverse reaction register. The frequency of common adverse reactions is already known because of clinical trials. According to some witnesses, what is important is what we do not know, the unknown reactions.

With regard to mandatory reporting by hospitals, as I said, since all adverse reactions will have to be reported, not just unknown and more serious reactions, hospital pharmacists are afraid their workload will increase significantly. Should the emphasis be on the quantity or the quality of adverse reaction reports? An increase in the number of reports could dilute the most valuable information.

A number of witnesses told us that the focus should be on unexpected adverse reactions. Is the frequency of an adverse reaction important? These are questions we are still asking ourselves in committee. We believe that this issue has not yet been resolved. That is why we are going to question the government about this in committee.

For example, one witness, Bruce Carleton, a senior clinician scientist from the University of British Columbia and B.C. Children's Hospital, suggests looking at human genetics and drug biotransformation. According to Dr. Carleton, drug reactions have a genetic basis. If further genetic research were conducted, it would be possible to predict and avoid adverse drug reactions.

This is an indication of the complexity of detecting adverse reactions. We would have liked to see a more innovative, proactive approach that goes beyond just adverse drug reaction reporting. As I said, this is known as pharmacogenomics.

One of the major concerns we had in committee about the creation of a register of adverse effects and adverse reaction reporting by hospitals pertains to the method of post-market monitoring. As I said earlier, the effectiveness of post-market monitoring will depend on how the register of adverse drug effects is structured and on the effectiveness of feedback from health professionals, including pharmacists and physicians.

It is not enough to simply create registers and collect data. In her testimony on April 10, the Auditor General said that there were weaknesses in the analysis and interpretation of adverse events, and there was no proactive system to identify patterns that could signal a serious safety concern.

The committee's work could have enlightened the minister about this bill. As I was saying earlier, we would have liked for him to wait for our reactions and our recommendations after our three-month-long analysis on pharmacovigilance. Some witnesses also suggested that an independent evaluation board be created.

What about that? Will the bill cover that? We know that clinical trials are done by the manufacturers, and that often, a number of adverse effects are known, but are not revealed and the drug is put on the market. We would have liked to see an independent evaluation board, and a number of witnesses agreed.

The life cycle of a drug will supposedly be extended, but we would like this to be done not only by manufacturers, but also by an independent evaluation board throughout the life cycle of the drug. We know that drugs are often tested on certain patients, but other groups of people have not been tested—for example children and seniors—and often, these drugs have serious adverse effects if they are used.

The creation of a research centre of excellence, in partnership with our universities, has also been suggested. This centre could engage in pharmacoepidemiology studies that would be required by law and funded by the industry, but not conducted by the industry, which is currently the case. Another guide was suggested, one that would be much more proactive and independent in relation to the pharmaceutical industry.

Any mandatory adverse reaction report will be ineffective if not dealt with properly. That is more or less the conclusion reached by several witnesses who want the government to do something about this. Will Bill C-51 address all those concerns?

For now, as I said earlier, some drugs have been taken off the market, but they could have been not put on the market right away in the first place. The industry could have waited for further clinical trials to be done.

There are also fears that there is an attempt to shorten the process before a drug is put on the market. There are some fears about the life cycle of the drug and following it after it goes on the market. That is a step in the right direction, but there is also a fear that this would shorten the period before the certification of clinical trials. We heard this from several witnesses. Thus, the life cycle of a drug should not be an excuse for premarketing studies to be reduced nor for the door to be opened to such a possibility.

A number of witnesses have told us that they would like the minister to be open to certain amendments they would like to see made to this bill. It is hoped that the minister and this government will be open to the decision made during clause by clause consideration of the bill.

As I was saying earlier, the regulations are not yet available. Will they be satisfactory? It is hard to say. It is rather a blank cheque right now. We know that the regulation will give life to the bill.

The vote here in Parliament will send the bill to committee, as I think all hon. members want to address it. Work will be done in committee.

Nonetheless, we hope—I am saying this again because I do not want anyone to forget it—that the minister will be open to the various voices that have been heard. For three months, we have been studying the drug monitoring program and the new life cycle for drugs, which takes a different approach, namely that trials continue after the drug is put on the market, in the interest of human safety.

For example, we know that some people have died after taking certain drugs. We also know that often, for genetic reasons, some drugs should not be given to certain patients. There needs to be openness in order to better address this whole issue. We have to take into account all the problems we have in properly understanding the effects of drugs on patients, those who use these drugs.

Labelling was also discussed. Warnings have to be issued, for example, if a person is sick and there is a contraindication to taking a certain drug. We would hope that the minister is open to that and that this will address the entire problem.

We are in the process of reviewing this approach. Given the openness of the parliamentary secretary, who sits on our committee, he can relay the questions to the minister. We are counting on his openness in this matter and we hope he will be proactive and sympathetic to our demands.

[Wayne Easter, Liberal, Malpeque, PE]

Mr. Speaker, I am pleased to speak to Bill C-51. In fact, as my colleague from West Nova said earlier in his remarks, these are two bills in a row, Bill C-51 and Bill C-52, that we are certainly most interested in moving forward to committee for further technical analysis and more research, but we do believe the bills in principle need to be carried forward.

The section of the bill with which I really want to deal is on the food side of it. I think there is strong interest in ensuring that products are indeed safe. I would say there is an almost public wave for stronger action in this regard. There has been the recent incidence of unsafe food. Health and consumer products have underscored the need to modernize the Food and Drugs Act. The fact of the matter is that the act was developed in 1953 and these amendments certainly update the bill.

Basically, the bill would amend the Food and Drugs Act and modernize the regulatory system for foods and therapeutic products. It would improve the surveillance of benefits and risks of therapeutic products through their life cycle. It is designed to increase compliance and enforcement measures by corporations to encourage them to report adverse reactions or potential health threats associated with market products. It would, I will admit, give substantial regulatory power to the minister.

I know there are some concerns about that. We have a number of letters already. That is why it is so important for the bill to go to committee relatively quickly, so that the witness lists can be prepared and those concerns can be addressed. We certainly support the idea of improving the safety and health of Canadians. We are committed to improving the safety and health of Canadians. We support measures to strengthen the regulatory system to ensure that Canadians are able to access the safest and most effective food in the world as well as with therapeutic products.

I want to turn mainly to the food area of the bill and that is in clauses 4 through to 6. The bill would create new offences relating to food, therapeutic products and cosmetics. It would require licensing for importing food and for the interprovincial trade in food.

In a previous Parliament there was Bill C-27. We in fact looked fairly extensively at the regulations surrounding the importing of food and the interprovincial trade in food. In all seriousness, there had to be improvements made in that area to ensure that imported food was safe and met the same kind of regulatory requirements as indeed Canadian food had to meet.

This bill in all areas would expand the regulatory authority, but in the food area it would expand the power of inspectors. I want to point out that it is not our intent nor do I believe it is the government's intent or even the bureaucracy's intent that the expansion of the powers of inspectors is to be overbearing. It is to ensure that the human resources and the authority are there to deal with some of the incidences that can happen on grocery store shelves or that imported food can face.

I would put a caveat in. Those of us who are on the agriculture committee know that certainly more human resources must be added to the Canadian Food Inspection Agency for it to do its job. The government did indicate the other day that there are some budgetary measures in that regard, but there do need to be the human and financial resources for the Canadian Food Inspection Agency to do its job and the additional authorities granted to it through this bill.

I also want to underline the fact that one of the concerns that we raised at our committee level was that these costs should not be passed on to primary producers. We have had enough of that. Primary producers should not be the ones bearing the costs for food inspections in this country. That is a public safety and health and safety issue. It is a public responsibility and we would hope that the government takes that seriously and funds the Canadian Food Inspection Agency appropriately to do its job.

The new prohibited activity in the bill really gives the government the authority to take action if someone knowingly provides the minister with false or misleading information relating to any matter in this bill, whether someone knowingly is tampering with a food, therapeutic product or a cosmetic, including tampering with a label or package.

A number of years ago, we heard about a substantial number of those where people, as a hoax or a threat or an act of terrorism really, had sent out the word over the media or email, or by other means, that they had in fact tampered with a food product on a grocery store shelf. That creates tremendous concern among the consuming public. It certainly creates difficulties for the businesses so affected. Under this bill, I do believe there is more authority for the authorities themselves to deal with those matters where there are hoaxes or threats, or indeed actual tampering with food itself.

The other area in clause 4 will also prohibit the importing of food that is injurious to human health. That is an important aspect of the bill that was not there previously in terms of the trade that goes on. It is very important that imported food be treated in the same way as domestic food on the grocery store shelves, and that action be taken against companies or individuals who may have both exported into this country or the company that imported the food that is injurious to human health. That is a very important measure.

We tend, in this country, to take our food system for granted. Canadian farmers provide the safest food in the world. The problem is they are certainly not paid well enough for it. Canadians only pay 13.5% of their income and by early February, their food bills are paid for the year. We do not want anything to happen on those grocery store shelves that will reflect badly on the Canadian primary producers.

The last point that I would make, as I see I am running out of time, is a point I made the other day, but I will make it again. Canadian farmers do face a double standard from their own government regulations. We must be on a level playing field with the rest of the world. We cannot add another regulatory burden.

[Paul Szabo, Liberal, Mississauga South, ON]

Mr. Speaker, I forgot to raise a further issue with the minister.

In the communications I have received from a number of the groups, they have asked whether they can get some assurance that they will be able to appear before committee and that the government will support their appearance before committee to ask questions, if necessary, and to provide information which would help the committee assess whether any appropriate amendments could be made to Bill C-51 to make it even a better bill.

Could the minister give the assurance that the government will support these groups being able to come before the Standing Committee on Health?

[Christiane Gagnon, Bloc, Québec, QC]

Mr. Speaker, I have a few questions for the minister about Bills C-51 and C-52. We know that the bill will require more human resources and also a training budget. We are all anxious to see how the minister will meet expectations in implementing his bill.

In 2006, the Auditor General noted the lack of human resources, especially in the areas of training and the safety of therapeutic products, foods and cosmetics. There is a shortage of resources.

The minister mentioned natural products. He is certainly aware that there are delays in granting authorizations to sell natural products. That is my first question.

As for my second question, the minister knows that these two bills rely on regulations. Since the regulations do not yet exist, we will have a bill but will not know what sort of regulations will be made. These regulations could give us an idea of how the bill will be interpreted. Can the minister tell me when the regulations will be ready—

[Paul Szabo, Liberal, Mississauga South, ON]

Mr. Speaker, Bill C-51 is a long bill of some 75 clauses and it affects a number of other acts.

Members are already receiving correspondence from their constituents concerning natural therapeutic products. It will be a very significant issue for the government and Parliament to address with regard to the implications of the bill to these natural therapeutic products.

One of my constituents specifically wrote about her son who suffers from Lyme disease and requires certain drugs. It is not that these drugs would cure the problem, but they help in terms of quality of life or in the ability to control the effects of the disease. It is a very serious situation, and I know the minister is aware of that.

At the outset, there must be a declaration of the government that the implications of Bill C-51 will not be draconian in regard to the pricing or availability of natural therapeutic products so those who believe that those products are necessary for themselves or their family members will continue to have reasonable and appropriate access with appropriate health safeguards.

[Tony Clement, Conservative, Minister of Health and Minister for the Federal Economic Development Initiative for Northern Ontario]

moved that Bill C-51, An Act to amend the Food and Drugs Act and to make consequential amendments to other Acts, be read the second time and referred to a committee.

Mr. Speaker, I am thankful for the opportunity to speak to Bill C-51.

Overseeing food and health product safety is one of the most fundamental roles the federal government plays in Canadian society. Today there are so many health products available already and so many more are coming to market. We are in a time when Canadians are taking a deep interest in the safety of the foods they eat and the products they use. We are most certainly in a time when Canadians want to know that their government is taking safety seriously.

We know that the trust of Canadians needs to be won daily. Past performance is not enough.

That is why, in the Speech from the Throne last October, the government committed to introduce “measures on food and product safety to ensure that families have confidence in the quality and safety of what they buy.”

In December the measures started taking form as the Prime Minister announced Canada's new food and consumer safety action plan. Its goal is to modernize and strengthen Canada's safety system for food, health and consumer products. To support this goal, budget 2008 has invested $113 million for the next two years alone.

The next step is to update our legislation to give us the tools we need to better protect Canadians. This is why Bill C-51 is before the House today. The Food and Drugs Act is 50 years old and many of its provisions no longer reflect today's reality. Bill C-51 seeks to modernize it through a new approach updated for the global economy. This new approach is based on preventing problems in the first place, targeting the highest risks and responding rapidly to problems as they arise.

Let me take a few moments to describe some key elements of Bill C-51. This bill enhances our legal framework to protect and promote the health and safety of Canadians in the areas of health products and food. While it covers many activities in a very diverse field, among the most important is the fact that Bill C-51 seeks to change much of how health product licensing takes place in Canada.

Currently under Canadian law, no one can simply start to manufacture or sell the kinds of health products covered by this bill. No one can simply start a clinical trial designed to test a new health product. A Government of Canada licence is needed, which is only issued after important conditions are met. When it comes to health products, the basic test for licensing is this: Do the product's potential benefits outweigh the potential risks?

The problem with the old approach under the Food and Drugs Act is that once a company has that licence, there are few measures to require ongoing confirmation that a drug or some other product meets this safety test, even if new or greater risks become known. As a result, Canadian requirements for companies to track the safety of their marketed therapeutic products are out of step with other leading regulators.

Of course, the vast majority of companies live up their obligations to consumers, but the absence of a framework that compels them to does not meet the expectations of Canadians or of this government. Bill C-51 addresses that gap between what we have and what we want.

Our rigorous approach to health product licensing will continue. However, the bill aims to provide the government with the tools that will allow it to require ongoing assurances that health products meet standards once they are on the market. These tools will also allow the government to intervene and order a recall, if necessary.

It establishes what we call a life cycle approach, a continuous system for monitoring the safety, the efficacy and the quality of drugs and other therapeutic products. It starts with the clinical trials that a company has to conduct before being permitted to bring its product into Canada's market. That stage normally provides information needed to spot and prevent possible safety issues.

At every step of the way, throughout the entire life cycle of a product, our government's scientists will use the latest evidence to assess whether the product's benefits continue to outweigh its potential risks.

By taking this life cycle approach, our oversight will target the highest risks and give us the information we need to respond rapidly as soon as we identify a problem. The constant flow of information will make it more likely that threats to safety and to health are identified promptly and acted on much more effectively.

The proposed bill also advances safety by authorizing the development of regulations to require more reporting of adverse drug reactions. It paves the way to work with the provinces and territories to make it mandatory for hospitals to report these adverse drug reactions. That step will generate more information for improved drug safety. As a result, problems can be caught earlier and responded to faster to better protect Canadians.

Similarly, Bill C-51 seeks to ensure that Canadians will generally have easier access to pertinent information about health products.

This bill contains provisions that will make the regulatory system more open and more transparent so that Canadians can obtain the information they need about the risks and benefits associated with products and make informed choices.

Industry generally takes consumer safety very seriously and cooperates with governments to address consumer safety concerns when they arise. However, for those few suppliers that do not cooperate, the proposed legislation includes measures to help ensure that corrective action is taken.

This includes the ability to order the recall of a health product from the Canadian market, when appropriate, to protect the health and safety of Canadians. We need this power if we are to respond as rapidly as possible to problems as soon as we learn about them to better safeguard the health of Canadians.

Under the bill, those few companies that are insufficiently concerned with the health and safety of the people who use their products would also experience significantly higher penalties for their actions.

For a very long time the maximum fine for health products under the Food and Drugs Act had been just $5,000. The bill proposes stiffer fines of up to $5 million for serious contraventions and will leave the ceiling open to the court's discretion when a supplier is found to act wilfully or recklessly. With greater deterrents in place, manufacturers will have even greater incentive to prevent problems from happening in the first place.

Together, the bill, and all of the work under the food and consumer safety action plan, sends an important message to Canadians and to the organizations that produce, import, distribute, and use the health products covered by the legislation.

The Government of Canada is taking consumer protection seriously and we are taking action. We are doing so in part through modernizing the Food and Drugs Act to prevent as many problems as possible, to target the highest risks and to ensure rapid response to problems as they arise. We are doing that by taking a health and food products safety system, which works well now, and making improvements so it works much better for Canadians.

I urge all parties to support Bill C-51 so that we can offer Canadians the system they want and need in order to ensure the safety of food and health products.

[Robert Thibault, Liberal, West Nova, NS]

With Bill C-51, with the progressive licensing, do you see an opportunity to improve the off-label situation? I don't want to stop off-label use. I understand that it's a necessity, but it seems that it has become almost systematic—most of the new pharmaceutical products used for children haven't been tested for children. They all end up being off-label, and you wonder if the proper information is getting around. Do you see some possibilities for improvement?

[Susan Kadis, Liberal, Thornhill, ON]

Thank you, Madam Chair.

Welcome to our guests.

To Mr. Ménard, are you familiar with the new proposed government legislation, Bill C-51, regarding life-cycle approach and progressive licensing? What is your position on this? Do you feel it will increase or decrease product safety for Canadians?