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

[Robert Thibault, Liberal, West Nova, NS]

Yes, Mr. Speaker, I believe it is. It gives the tools to the Department of Health. It gives the department the potential to ensure the safety of a product as its use evolves. Currently, all we can do is look at whether the product is safe for the use for which the application was made. With time, the use might become completely different than what was considered when that product was developed and when clinical trials were happening.

As I mentioned in my speaking notes, if we want to make the initial licensing so restrictive and so strict as to ensure our safety on all uses in the future, no therapies would ever come to market. No new drugs and no new therapies would ever become commercialized and Canadians would not have access to them.

I think this is a logical way to do it. It is a smart regulation. I do not know why we would ever have accepted stupid regulation, but this is an intelligent way of having regulation and ensuring safety.

It is important to have the necessary tools and the will at the Department of Health to impose those further clinical trials after the drug has been on the market for a certain amount of time. Again, that is going to require some cooperation from pharmaceutical producers.

[Paul Szabo, Liberal, Mississauga South, ON]

Mr. Speaker, I appreciate the commentary of the member, who is the health critic for the official opposition.

We have had some experience in the past through the reproductive technologies bill. It was supposed to take two years for regulations to come forward, but several years later we still do not have all of the regulations. I see here that there are other regulations.

My question for the member really has to do with the fact that half of the clauses in the bill would make consequential amendments to other acts. I do not know how many members of Parliament would be able to inform themselves as to the nature of those changes and whether they should access all the other bills to see if the changes would be meaningful.

Will the member undertake as part of the review, should the bill pass at second reading and go to committee, to ensure that Health Canada would provide to committee, which would therefore make it accessible to other members of Parliament, a proper explanation as to the rationale for the consequential amendments to other acts so we can be absolutely assured that we do not have other areas that should be examined and may impact areas of concern to the public?

[Robert Thibault, Liberal, West Nova, NS]

Mr. Speaker, that is a very good point. It is a point that is often overlooked by the House when we approve a bill. We saw it with Bill C-10. One small element of a regulation was missed by the House, but luckily it was picked up by the Senate, as it would have led to censorship in our film and television production.

In this case, there are a number of acts, such as the Canadian Food Inspection Agency Act, the Fisheries Act, and some agricultural aspects, which the next speaker will certainly want to raise. The joint administration and the cross-regulation between the Health Act, the Food and Drugs Act and other acts necessitate all these amendments.

These are some of the things that we certainly will be studying at committee. We will ask the Library of Parliament for the analysis, which it does very well. We have had the preliminary one. As well, witnesses will appear who can show us if there will be difficulties within their areas of jurisdiction or administration.

[Wayne Easter, Liberal, Malpeque, PE]

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

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

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

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

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

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

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

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

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

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

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

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

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

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

[Steven Fletcher, Conservative, Parliamentary Secretary for Health]

Mr. Speaker, I would like to point out to the member that $113 million over two years has been put aside in budget 2008. Naturally, we would like to thank the member for his support for that budget. I wonder if the member could explain his position on the life cycle approach and tell us if he supports his health critic on that approach to product safety.

[Wayne Easter, Liberal, Malpeque, PE]

Mr. Speaker, I am glad to see that those resources are there. However, I want to point out to the parliamentary secretary that we have seen this in the past, both with the current government and previous governments. The way the system operates in Ottawa is that sometimes there is a small cost recovery fee or the government is in fact paying the fees for certain measures and after a while, as time goes on or the cost recovery fee goes up, the burden of cost is passed down to others in the industry. We want to ensure that does not happen in this case.

In terms of the health critic for the Liberal Party, on this side of the House we do not say “yes, sir” or “no, sir”. We have strong debates in caucus and we will on this issue. However, when the decision is made, we operate as a team, and certainly I will be supporting my health critic in this regard.

[James Lunney, Conservative, Nanaimo—Alberni, BC]

Mr. Speaker, I appreciate the member's comments on the bill. I know the member comes from Prince Edward Island and I know that, having been out there, a lot of people in Prince Edward Island actually use natural health products.

He will remember, because I know this member has been in the House for a while, that over the years there have been discussions about the Food and Drugs Act and how to regulate natural health products. After a number of machinations, natural health products, which were promised to be a third category, ended up as a sub-category of drugs. Indeed, they have been regulated as a sub-class of drugs.

I wonder if the member has heard concerns from his constituents, as I certainly have, about the regulation of natural health products under this proposed bill. In fact, therapeutic products replace drugs and natural health products, so NHPs equal drugs and drugs equal NHPs except for the regulations. However, the bill has very serious and strong seizure, forfeiture regulations attached to this. Does the hon. member think it is appropriate for drugs to be applied to natural health products, is it a concern for him as we are hearing from some people across the country?

[Wayne Easter, Liberal, Malpeque, PE]

Mr. Speaker, indeed, we are hearing, and we had a discussion here earlier among members on this side of the House, about the concern that is coming forward from people in the natural health products industry. In my overview of the bill, I do not think it hurts the natural health products industry or helps it at this point in time.

However, as the health critic said, it is extremely important when the bill gets to committee that witnesses be brought in and that they have their say. If there are concerns, they should be addressed. I think the natural health products industry is a growing industry. These are more natural products and they get us off the drug hook, if I can put it that way.

[The Acting Speaker, Conservative, Andrew Scheer]

A very brief question or comment. The hon. member for Yukon.

[Larry Bagnell, Liberal, Yukon, YT]

Mr. Speaker, actually, my question was not brief, so I guess I will ask the short part. I have two emails. The short one reads:

I am opposed to the police state powers in Bill C-51. I want my access to natural health products protected and there is something wrong with the state making personal health decisions for us. Health decisions are fundamental to our personal autonomy.

I wonder if the member has any comments to that email.

[Wayne Easter, Liberal, Malpeque, PE]

Mr. Speaker, it is a legitimate question and it is one that should be addressed when the bill gets to committee with witnesses in that regard.

However, on the food side, which I generally talked about, we do need the authority as a government regulator to move rapidly if there are concerns in the system or a small issue becomes magnified and mushrooms into a huge issue.

I would suggest that those concerns should be addressed at committee. I do not believe there are police state powers in the bill.

[Christiane Gagnon, Bloc, Québec, QC]

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

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

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

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

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

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

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

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

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

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

Will the government meet the expectations of Canadians?

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Mr. Speaker, the New Democratic Party caucus also has concerns with regard to this legislation, specifically in the areas she addressed, and that is the safety of drugs and the shortcuts that can be taken in clinical trials.

I remind everyone that some years back the Liberals closed Health Canada drug labs and entered into what they called partnerships between drugs companies and Health Canada. That activity has compelled the NDP to take a very close look because it would seem to compromise the safety of some products.

Could the member opposite comment on that? Does she see a need to return to a more rigorous Health Canada review?

[Christiane Gagnon, Bloc, Québec, QC]

Mr. Speaker, I thank my colleague for her question.

We are in the process of looking at pharmacovigilance, and a number of witnesses came to tell us that they would like to have an independent board. We hope that the government also wants to extend the life cycle when it comes to the safety of a pharmaceutical product.

We would like an independent body with the authority to oversee the products on the market. Witnesses told us that they do not want to decrease the amount of time required for clinical trials of drugs before they are put on the market. They also hope that an independent body will then be able to monitor these drugs.

Some drugs are subject to clinical trials, but their adverse effects are often kept secret. They are not known. How is it possible, for example, that 51% of drugs present serious side effects after being put on the market? Would it not be good for an independent body to also have the oversight on these clinical trials, instead of leaving it to private enterprise?

[Steven Fletcher, Conservative, Parliamentary Secretary for Health]

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

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

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

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