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

This bill was last introduced in the 39th Parliament, 2nd Session, which ended in September 2008.

Sponsor

Tony Clement  Conservative

Status

Second reading (House), as of June 10, 2008
(This bill did not become law.)

Summary

This is from the published bill. The Library of Parliament often publishes better independent summaries.

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.

Elsewhere

All sorts of information on this bill is available at LEGISinfo, an excellent resource from the Library of Parliament. You can also read the full text of the bill.

Food and Drugs ActGovernment Orders

April 30th, 2008 / 3:20 p.m.
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Parry Sound—Muskoka Ontario

Conservative

Tony Clement ConservativeMinister of Health and Minister for the Federal Economic Development Initiative for Northern Ontario

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Food and Drugs ActGovernment Orders

April 30th, 2008 / 3:30 p.m.
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Liberal

Paul Szabo Liberal Mississauga South, ON

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

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

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

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

Food and Drugs ActGovernment Orders

April 30th, 2008 / 3:30 p.m.
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Conservative

Tony Clement Conservative Parry Sound—Muskoka, ON

Mr. Speaker, I am happy to address the member's comments at this time. I state categorically and for the record, there is nothing targeted to the natural health products industry in the bill. There is nothing that is draconian in terms of the effects of pricing and availability in the bill. Indeed, we seek to ensure that natural health products are available to Canadians.

Of course we are always concerned about safety and efficacy, particularly safety. Natural health products, just as prescription drugs and certain other therapeutic products, have to be available in a safe way to Canadians.

I would say for a purveyor or manufacturer of a natural health product, if what is on the label is accurate and if what is claimed about the natural health product is accurate, there is nothing to fear from the legislation. Indeed, our government and our caucus want more natural health products on the marketplace for more choice for Canadians, but we will not stand by if there is a dangerous product.

I issue warnings practically every week about this or that dangerous product, some of which are natural health products, which can have an impact on cardiac arrest, strokes or liver damage. Things can have this kind of impact. We do not want those products available. We want Canadians to be warned and we want them to be safe.

Food and Drugs ActGovernment Orders

April 30th, 2008 / 3:30 p.m.
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Bloc

Christiane Gagnon Bloc Québec, QC

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

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

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

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

Food and Drugs ActGovernment Orders

April 30th, 2008 / 3:30 p.m.
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Conservative

The Acting Speaker Conservative Andrew Scheer

The hon. Minister of Health.

Food and Drugs ActGovernment Orders

April 30th, 2008 / 3:30 p.m.
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Conservative

Tony Clement Conservative Parry Sound—Muskoka, ON

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

First, with regard to funding and human resources, it is important to invest in these areas so that these bills can provide a solution. As I said, budget 2008 includes more than $100 million for the next two years and more than $500 million for the next five years for human resources and the other obligations arising from these bills.

Second, the regulations are also very important, of course. There will be many opportunities in future to discuss the regulations. It is important that these bills act as an umbrella. It is important for Parliament to discuss the regulations.

Food and Drugs ActGovernment Orders

April 30th, 2008 / 3:35 p.m.
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Charleswood—St. James—Assiniboia Manitoba

Conservative

Steven Fletcher ConservativeParliamentary Secretary for Health

Mr. Speaker, I think many Canadians would be surprised that the federal government in the past has not had the power to recall items. Could the minister give us a couple of day to day examples of what the bill would do to empower the government to have that?

Could the minister also elaborate on what has been called the life cycle approach. I think that is a concept with which many Canadians may not be familiar. Could he explain how that will affect a product, not today but two years, five years, fifty years down the road?

Food and Drugs ActGovernment Orders

April 30th, 2008 / 3:35 p.m.
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Conservative

Tony Clement Conservative Parry Sound—Muskoka, ON

Mr. Speaker, I think many Canadians would be surprised to learn that the Minister of Health and the Government of Canada do not have the power of recall under the Food and Drugs Act presently, except for food, but for other products, therapeutic products, for instance, that is not the case.

Therefore, we are left in the situation where if Health Canada believes there is a dangerous product on the shelves, whether it be a prescription drug, or a natural health product or some other therapeutic product, we presently have to negotiate with the manufacturer and the distributor to get the product off the shelves. We are left with merely issuing warnings on websites and various media outlets not to take this product because it has a deleterious effect.

Therefore, that is a problem. In the last resort, at the very least, we want to have the ability to recall.

In respect to the member's question on the life cycle approach, in a nutshell, we would have the same standards available for approving, let us say, a prescription drug at the beginning of the process, but we would still concern ourselves with any additional studies, or information or evidence of adverse reactions that occur as a drug is distributed throughout the country as a medicinal product.

Therefore, we do not stop our concern just as the product is licensed. We continue our concern throughout the life of that product.

Food and Drugs ActGovernment Orders

April 30th, 2008 / 3:35 p.m.
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Liberal

Paul Szabo Liberal Mississauga South, ON

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

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

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

Food and Drugs ActGovernment Orders

April 30th, 2008 / 3:35 p.m.
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Conservative

Tony Clement Conservative Parry Sound—Muskoka, ON

Mr. Speaker, I do not chair the committee, but it would strike me as reasonable that this approach be seriously considered by the committee chair.

What I can tell the hon. member is we have engaged in numerous discussions with various stakeholders in the natural health products area. We continue to have those discussions. There is a lot of misinformation out there. Quite frankly, there has been some scaremongering about the intent and the effect of the bill. We are trying to have a reasoned conversation with people to ensure they realize that this is not an attack on the industry. This is not designed to shut down the availability of their products.

This is designed to protect the health and safety of Canadians and there are certain things found in the bill that will apply the proper balance between the right to commerce on the one hand, but our rights to safety as Canadians on the other. I think that is appropriate.

Food and Drugs ActGovernment Orders

April 30th, 2008 / 3:40 p.m.
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Liberal

Robert Thibault Liberal West Nova, NS

Mr. Speaker, there have been discussions between the parties, and I think if you were to seek it you would find unanimous consent that I be permitted to share my time with the member for Malpeque.

Food and Drugs ActGovernment Orders

April 30th, 2008 / 3:40 p.m.
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Conservative

The Acting Speaker Conservative Andrew Scheer

Does the hon. member have the unanimous consent of the House to split his time?

Food and Drugs ActGovernment Orders

April 30th, 2008 / 3:40 p.m.
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Some hon. members

Agreed.

Food and Drugs ActGovernment Orders

April 30th, 2008 / 3:40 p.m.
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Liberal

Robert Thibault Liberal West Nova, NS

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.

Food and Drugs ActGovernment Orders

April 30th, 2008 / 3:50 p.m.
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Charleswood—St. James—Assiniboia Manitoba

Conservative

Steven Fletcher ConservativeParliamentary Secretary for Health

Mr. Speaker, I thank the member for his speech and for what appears to be a very thoughtful and cooperative approach to this government legislation. I think it demonstrates that this Parliament has the potential to work very well in that together we can move forward legislation that is important for Canadians.

I have a question for the member. The life cycle approach has a lot of merit, I think, and we have heard the minister speak to that. I wonder if the member would agree that the life cycle approach is the right approach to take when it comes to products such as those we are discussing today.