Hon. Tony Clement (Minister of Health and Minister for the Federal Economic Development Initiative for Northern Ontario, CPC)
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.
He said: 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.
Hon. Robert Thibault:
Mr. Speaker, I thank all members of the House.
I do not want to shock the minister while he is still present in the House, but it will come as very difficult news to him that for two days in a row we have to find some level of agreement with the bill that he proposes to the House of Commons. I am looking forward to this bill being at committee and to having the opportunity to further explore it.
I am pleased with the answer he gave to the member for Mississauga South. It is consistent with the discussion I had with the parliamentary secretary as to the fears out there about natural health products and natural therapeutic products not being targeted by this bill. I think that fear was out there, so I think this will be necessary. As I understand it, we can be assured of the government's cooperation if modifications have to be made in the definitions or in the bill so that this can be clearly drawn out.
That leaves one area of concern that I have been receiving as critic and which members undoubtedly will hear about. It is the question of direct to consumer advertising. While I understand from the bureaucrats or the minister's officials that there is no intention in this bill to permit direct to consumer advertising, it does somewhat change the way it is dealt with.
In the past it was directly in the bill. The bill said that the only advertising on prescription products would be the name, quantity and price. They were the only things that could be advertised. In this case, my understanding of it is that this gives the governor in council the potential to write regulations concerning advertising.
My understanding is that it is not the intent to open up the advertising, but it does take it out of the hands of Parliament and of the committee. That would cause some concern, so I hope that the government, at committee level, will be willing to look at some modifications to the bill, some amendments that might clarify this.
It could be done in one of two ways. One is that we could do the process that we have used in certain elements of the Health Act, which is to bring the regulations to committee for approval. We could limit it to those regulations concerning advertising, because it does not have to be all the regulations permitted under the act, or an amendment straight to the act. I will give some time for the government to consider those amendments before it comes to the committee. Hopefully, they will be negotiated amendments. If not, I am sure we will have some present.
That being said, I think the principles of this bill are quite good. This is not a bill that has been dreamt up in the last few weeks by the government. This bill is a result of a process of discussions and consultations that has been going on since 2003. These are part of the process that was known at the time as the smart regulations process. We were looking at regulatory reforms to the Government of Canada acts that necessitated those regulations to see if there was not a better way to do it, to be competitive internationally and domestically, and to at the same time protect Canadians.
One of the elements that comes in here is drug safety. The assurance of drug safety is very difficult. As the minister pointed out, the test on permitting or licensing of pharmaceutical products is whether the potential benefits outweigh the potential risks. We do not necessarily know when that first evaluation is done what the use of that pharmaceutical product will be in time, whether it will evolve from when the original clinical trials were done, and whether other drugs or therapies will come on stream that might interact with it. We do not know that.
Here we are going with the principle that has been known as progressive licensing and is now termed life cycle approvals or a life cycle approach. I do not know what it could be called that would reflect its true nature, but what it does is say that to get on the market initially the product has to meet the same safety criteria as it is currently meeting. The criteria are not relaxed.
Once the product is on the market, Health Canada has the ability to order further clinical trials or withdraw the licence if there is no compliance. I think that is important, because there could have been such a strict restrictive process, so as to assure absolute safety, that no new pharmaceuticals would ever come on the market.
However, with this process, we assure the safety of the product through clinical trials, and then we have time to do the evaluation as it is being used in the market, because the absolute use might be different from the use that had been foreseen. We heard at committee that the United States food and drug regulations use the 10,000 dosage system. After 10,000 dosages, they do a re-evaluation. Here, it could be different for any therapies.
However, once the experts at Health Canada see how a drug is evolving in its use, they can order further clinical trials at any time. I think it is important to try to understand what this means.
Number one, we know that almost no pharmaceuticals, and I could almost say zero, are approved for use by children. They are very seldom approved for use in pediatrics because it is so difficult to do clinical trials for pediatrics. The clinical trials before the first approval of a drug are done with adults. Then, over time, dosages or uses of prescriptions are studied by specialists in their work. When they find there is some value for use in pediatrics, they try to find the right dosage.
A drug might be developed for one specific use. For example, we have heard about Viagra being used in pediatric care, and while a drug might be developed for one specific use, it can be found through time that it is even more useful for other conditions that had not been considered. This is called off-label use.
I remember reading not so long ago about a cancer drug being used for macular degeneration. It was just as effective as the drug that had been used for macular degeneration. Thus, we can see how a drug might be used in a therapy other than the purpose for which it had its first clinical trials.
We now have the ability, with this bill, for Health Canada to order clinical trials in that area of use and in that population. If we discover with time that the major use of a certain therapy or pharmaceutical product ends up being done by seniors, those between the ages of 50 and 65, then perhaps Health Canada could order that a specific clinical trial be done in that area. If it is for people who have certain diseases and there are risks, we can do those things.
That is a logical, smart approach, which permits the drug to come on the market under the same criteria that it does now. This is what I think Canadians have to understand: this is not the relaxation of the initial criteria. It is a reasonable, intelligent way of monitoring the use of that product over time and changing the licensing standards.
Again, I think it is important to respond to the scare that is being put out there, because there are a lot of Canadians who are finding very good benefits in using non-prescription health products, therapeutic products, natural health products, organics, or whatever we want to call them. They are under different names. People are concerned when they see this bill that it might mean they can no longer access those products. I have had calls about this, as all the members of Parliament will.
I take the minister at his word. When I read the bill, I did not see any effect on the natural health product directorate and I did not see that these products were moved, but the fear is out there among Canadians and I think we will have to ensure, before the bill goes through the House of Commons and the Senate, that it is cleared up.
Yesterday when we were looking at Bill C-52, I raised a question on the power to recall and said that we have to be careful. We have to be careful that the power to recall does not become an obligation to recall. If we give the power to the minister and his inspectors, we have to make sure that this power is used only when all other methods fail and only when all other methods have been attempted, because we do not know of any problems we have had so far. So far, negotiations have been successful.
I see that my time has run out. I thank members for their attention.
Hon. Wayne Easter (Malpeque, Lib.):
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.
Ms. Christiane Gagnon (Québec, BQ):
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.
Ms. Judy Wasylycia-Leis (Winnipeg North, NDP):
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
Mrs. Irene Mathyssen: Nor will we.
Ms. Judy Wasylycia-Leis: 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.
Mr. Steven Fletcher (Parliamentary Secretary for Health, CPC):
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.
Mrs. Joy Smith (Kildonan—St. Paul, CPC):
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—