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

[Christiane Gagnon, Bloc, Québec, QC]

Mr. Speaker, I will reply to the Parliamentary Secretary for Health.

I am not negative; I am quite open. It is not about the life cycle approach. We have to look at the life cycle of a drug so that it is analyzed and tested even after being put on the market. I am saying that there are certain fears.

I believe that in a democracy we can express these fears. To show our good faith, we will vote for the bill to be sent to committee. My intention is not to be negative. It may be a good idea, but is it the best idea? Perhaps the intentions are good. The intention is still there. However, perhaps some amendments could be introduced. The minister may find that it is a good idea to have certain safeguards, for example.

We are worried about the criteria from the International Conference on Harmonization of Technical Requirements. We know very well that it wishes to reduce regulation. It would like to shorten the approval process for drugs and lower standards of protection in order to reduce drug development costs and the time required to bring drugs to market.

It is well known that Health Canada collaborates with this organization. Therefore, we simply want to establish certain safeguards. I believe that one of our responsibilities when studying the bill is to shed some light and ensure that we all understand what the witnesses have come to tell us.

[Larry Bagnell, Liberal, Yukon, YT]

Mr. Speaker, I know government representatives are in the lobby watching this on TV. I would ask if the department could answer my two emails in writing, the one I referred to in my last question and the one I will read now. I also would like the member to answer these questions as well.

The email states:

The consequences of this Bill from, what I can understand, are far reaching. The search and seizure, as well as the fine possibilities are frankly scary. I feel that this Bill could be trying to limit our access to natural food products and potentially put natural food stores out of business. In these days of recession, this is hardly time to be putting legitimate businesses into receivership, not to mention the risk to Canadian rights and freedoms.

Here are my questions:

Will this new law be used to abuse and punish special interest groups, minorities, religious groups or others?

Why do bureaucrats want to bypass Parliament and Senate's approval to create new laws?

Why do bureaucrats want seizure warrants without judge approval?

With fines being increased a 1000 times, and seizing authority without a warrant, is Bill C-51 meant to bankrupt and silence its target audience?

Could the member provide some answers for my constituent who sent this email to me?

[Christiane Gagnon, Bloc, Québec, QC]

Mr. Speaker, I believe that the goal of this bill is to reassure the public about food safety, the safety of therapeutic products and the safety of products for sale on the market to ensure that they do not contain toxic elements.

The industry must therefore conform to certain standards. We currently import many products from other countries that may not have the same standards as Canada does. We need to strike a balance with the viability of a company.

In the newspapers over the past number of months, we have seen recalls for toys and medications that put many peoples' lives in danger. In some cases, people did die. In my opinion, a balance must be struck. As the member said, if searches are conducted without a judge's approval, we should look at this in committee.

In my opinion, when a company puts peoples' lives in danger, we have to put the safety of people before the viability of a company that has been delinquent in terms of standards, regulations and the law. I believe this protects us.

[The Acting Speaker, Conservative, Andrew Scheer]

It is my duty pursuant to Standing Order 38 to inform the House that the questions to be raised tonight at the time of adjournment are as follows: the hon. member Rimouski-Neigette—Témiscouata—Les Basques, Private Lumber Producers; the hon. member for Kitchener Centre, Ethics.

[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

[Irene Mathyssen, NDP, London—Fanshawe, ON]

Nor will we.

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

My colleague from London—Fanshawe says, “Nor will we”. That is why I bring to this debate my concerns.

However, that is not to say that there are not some good provisions in this bill. I do recognize that the government has moved a significant distance from the days of the Liberals. Ironically, this legislation is more proactive than the Liberals ever presented to this House. However, it still has lots of problems and it still does not mean we will be supporting it but it is a step forward.

I would like to point to a couple of those initiatives. The bill has provisions for the recall of drugs and food products that have contaminants. The bill sets out hefty fines for corporations that do not reveal problems or side effects with drugs. There is new emphasis in this bill around ensuring that government has the tools to protect Canadians. I commend the government for those initiatives and I support those aspects of the bill that take us forward toward what I consider fundamental to this whole debate and that is a do no harm approach when it comes to food and drugs.

However, beneath those specific clauses and the fine words of the press release that the Prime Minister and the Minister of Health presented to Canadians about safety first, there are enough concerns to make me and others suspicious of what the government is all about and where it is trying to lead us.

We only need to look at a couple of the areas that we have heard about to date. I hear some of my colleagues on the Conservative benches chuckling. I do not think they would chuckle if they were to listen to the words of Dr. Barbara Mintzes, who has brought to the attention of the House a clause in the bill that appears to move the government closer to direct to consumer advertising. That is so well documented that some of the officials have already said that they acknowledge that is a problem and maybe it needs to be addressed.

Why is that important? Do we want to see another $6.3 billion added to our pharmacare bill? Do we want to see big pharma pushing their drugs on Canadians without scientific basis? Do we want to see full-blown advertising in this country, as is the case in the United States?

Is it not enough that we have this grey area where drug companies can find a loophole and advertise all they want the lifestyle and create the appearance of something helping this person without naming the drug. We need only to look at the Viagra ads. They are pretty clear and impressive and they have led to all kinds of people demanding prescriptions for certain drugs from their doctors without necessarily a basis in terms of either their condition or the science available.

Direct to consumer advertising is just one of the problems in the bill that will make us very cautious about supporting it. Unless this loophole is closed and there is a firm commitment from the government to absolutely close the door to direct to consumer advertising, which not only means where we are today but going back and closing the door in terms of the loophole, there is no way in the world we should support the bill because of the ramifications it would have for our entire health care system, a system where costs for pharmaceuticals are now outstripping all other aspects of the system.

I will give another example. We have heard mentioned in the Chamber today the words “lifecycle approach” to drug surveillance or “progressive licensing”. It all sounds great, innovative and progressive but we need to realize that underneath it all there could very well be an agenda to speed up the approval of drugs at the front end and create the illusion of safety or the reality of safety at the other end.

However, what does it matter when we have already digested a drug that is not safe and has produced serious health consequences? Can it be that the government has listened to the drug companies when they say that they would rather deal with expensive lawsuits and pay out big money after being sued than to put in the money that is needed at the front end to ensure that the drugs are safe in the first place?

The real question we have to ask today is the one Alan Cassels and others asked in the media when the bill was released. Would this bill prevent another Vioxx? Would it stop a situation where hundreds of thousands of people are dying because they took a drug without realizing there were serious side effects unrelated to the condition for which they were taking it? What in this bill would stop that? Where is the inspection force? Where is the apparatus? Where is the infrastructure to make that happen? Where is the commitment from the government to deal with contaminated drugs coming into this country? How will the government handle another heparin, a contaminated drug from China? Is it prepared to send inspection officers to manufacturers in China? Is it prepared to put surveillance officers at the border? Is it prepared to take seriously the side effects that Canadians talk about? Is it prepared to act the minute there are serious reactions to drugs?

I hope that is the case. I do not know if that is the case. I do not know if this bill would do that. I want to keep an open mind about that. When we get to committee, I want to ask those questions. Witnesses will testify. We are going to seriously study that aspect. The fundamental bottom line when it comes to this bill is, is it going to stop another Vioxx? That is the question. How will it do it? Will it do it in time? Will it really make drug companies provide the information that they may have held in secret which may reveal something? Would it have been able to get out of Merck Frosst the information around Vioxx that it kept secret that would have prevented hundreds of thousands of deaths?

Those are two areas of concern. There are others.

We have received hundreds of letters from people concerned about natural health products. We have been inundated with letters and communications expressing concern about this bill and whether or not there is a hidden agenda to bring natural health products under the rubric of drugs, after the huge battle we have had in this House for a decade to have a separate category for natural health products. This is something that the Conservatives took up with a vengeance some 10 years ago, which led to a health committee discussion and a report, which led to the establishment of a third category, which led to some reasonable approach to dealing with natural health products. Unfortunately, both the Liberals and the Conservatives since then have botched the whole plan. We now have hundreds of thousands of natural health products waiting in line to be assessed and licensed.

The question here is, is this a way to get around that? Is this an attempt to deal with the backlog like we have seen with immigration? Perhaps it is similar to the budget implementation bill and slipping immigration into that bill. We do not know.

Needless to say, when it comes to this area, there is nothing more important than how we protect people in terms of the drugs and the medications they have to take and the food they have to eat. It is the job of government to put safety first, to ensure that products on the market are as safe as possible. That means a proactive government, tough regulations, adequate resources, a government with the will to make safety fundamental and to put people before drug profits.

[Brian Fitzpatrick, Conservative, Prince Albert, SK]

Mr. Speaker, I was astounded to listen to the member's presentation and the one from the Bloc as well. I have come to the conclusion that maybe we should have a special law that prohibits big corporations from distributing and selling prescription drugs to NDP members and their supporters, and maybe Bloc members as well, because we would not them to take something they feel is unscientific and would not have any benefit.

Let us be clear. For every drug cleared through the clinical trial process, there are literally thousands of drugs that do not get to first base. This is not a slam dunk process and it costs an awful lot of money. There are a lot of other safeguards. The EU has a clinical process that is very tough. The Japanese have one that is very tough. The Americans have one that is very tough. If manufacturers fail in the United States, they get through the entire process and get a drug approved but if they make a mistake, they can be financially ruined by the American tort system.

However, for members of this House to say that we are just allowing drugs on to market without any due diligence or any comprehension for public safety and that there is some great conspiracy between members of Parliament and the drug companies to foist all these poisonous and toxic drugs on people is total nonsense. I cannot believe the member actually believes that. I do not want to disagree too strongly with her opinion because it might insinuate that I am challenging her intelligence.

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

Mr. Speaker, this is a very serious matter, not a laughing matter. It has to be debated in the context of the health and well-being of Canadians. I make my comments with all seriousness and based on significant input from many Canadians.

As I also said, we will pursue every one of those concerns at committee to determine the legitimacy. No one is making generalizations without basis in fact. No one is casting aspersions without any reason.

We are here today with one of the most important pieces of legislation this Parliament has seen in a long time. We are questioning on the basis of evidence that has been provided to us. I do not need to tell anyone how many Canadian lives are put at risk every day because we do not have an adequate safety system right now. All I have to do is read through the papers and list off numerous cases.

Maybe the member is interested in this one, if he is not interested in some of the others. It is a recall order for a product for erectile dysfunction. This is Libidus, an unauthorized product promoted on the manufacturer's website as treating erectile dysfunction, saying it does not produce health risks. Well it does. Where is the government?

How about Evra, a birth control product for women, a patch that produces blood clot risks. Why is that? Why are young women at risk right now as we speak?

What about the drug to quit smoking that came out not too long ago, Champix, which produces all kinds of psychiatric side effects?

What about as I mentioned, heparin, in which contaminants were found after production in China?

What about all of these examples? Does it not matter? Should Canadians not feel safe? Is that not what we are here for? It is not to put people at the will of the marketplace and let them take chances. It is about trusting government, and if we cannot trust government when it comes to the safety of the drugs we have to take and the food we have to eat, then when can we trust government?

[Steven Fletcher, Conservative, Parliamentary Secretary for Health]

Mr. Speaker, unlike my colleague from Prince Albert, I actually love the loony left. The loony left allows average Canadians to see the ridiculousness of the arguments. I commend the member on the passion of her case, but I think the member knows that she is mistaken on numerous points including the suggestion that products or drugs coming onto the market are less safe. This bill does not deal with that. The drugs that have come onto the market are under the same regime with or without this bill. That is important for the member to know.

On the issue of direct consumer advertising, the member also knows that this government is in court to prevent direct advertising of pharmaceuticals to the Canadian market. The member knows that and this bill in fact strengthens the government's position on that.

I would also like to read to the member proposed section 2.3 of the bill:

The purpose of this Act is to protect and promote the health and safety of the public and encourage accurate and consistent product representation by prohibiting and regulating certain activities in relation to foods, therapeutic products and cosmetics.

We can see that the intent is in the best interests of Canadians. I would ask the member to put aside the worries about the black helicopters, put away the tinfoil hats and come to committee with an open mind. All the other parties are. We are. If there are reasonable suggestions for amendment, we will listen to them. Will the member come to committee with an open mind and listen to the facts and read the bill for what it is, an improvement to the health and safety of Canadians?

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

Mr. Speaker, you will know that I have already said that we come to this whole process with an open spirit, wanting to know if in fact the substance of the bill meets the rhetoric of the government. We enter the process willingly and with open minds.

I just wish the hon. member were open to some of the concerns being raised because when he suggests that this is about the loony left speaking, he is insulting thousands of Canadians across the country who are raising concerns. He is actually casting aspersions on Dr. Mary Wiktorowicz. He is casting aspersions on Joel Lexchin, on Dr. Barbara Mintzes, on Dr. Steve Morgan and Alan Cassels, many people who came to our committee and expressed their concerns. So, I hope he is open and I hope he is willing to actually amend the bill when those concerns have been substantiated.

[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, those are all questions that need to be addressed by the government and vetted at committee. I certainly hope the member will encourage those who have raised these concerns to present them in writing to the committee or in fact to attend our committee hearings.

I hope that we will have a wide open, serious, indepth review of the bill in terms of all of its aspects, because when it comes to judicial oversight and RCMP investigations, as he has mentioned, these are very serious issues. When we are talking about direct to consumer advertising, progressive licensing, natural health products, oversight, investigative forces and discretionary powers, all of those issues are critically important in an area of such fundamental importance.

I look forward to a very serious debate and indepth discussion on this bill.

[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.

[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.