House of Commons Hansard #45 of the 38th Parliament, 1st Session. (The original version is on Parliament's site.) The word of the day was industry.


Tax Conventions Implementation Act, 2004
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Some hon. members


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The Acting Speaker (Mr. Proulx)

The question is on the motion. Is it the pleasure of the House to adopt the motion?

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Some hon. members


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The Acting Speaker (Mr. Proulx)

I declare the motion carried.

Consequently, the bill is referred to the Standing Committee on Finance.

(Motion agreed to, bill read the second time and referred to a committee.)

Food and Drugs Act
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Joe Volpe for the Minister of Health

moved that Bill C-28, an act to amend the Food and Drugs Act, be read the second time and referred to a committee.

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West Nova
Nova Scotia


Robert Thibault Parliamentary Secretary to the Minister of Health

Mr. Speaker, I am pleased to speak in support of Bill C-28 which proposes two amendments to the Food and Drugs Act. These proposed amendments would provide the Minister of Health with the authority to allow Canadians faster access to a wider variety of safe and nutritional food products. Before I speak about the bill, I will provide some context to the reason the bill is being proposed.

The first proposed amendment responds to the concerns of the Standing Joint Committee on the Scrutiny of Regulations on the legal status of regulations that currently permit the issuance of notices of interim marketing authorizations under the food and drugs regulations.

These notices allow the earlier availability of safe foods in the Canadian marketplace while the formal process is undertaken to amend the regulations. That is quite important to a lot of producers, to a lot of consumers and to industry so that we can get these products on the shelves as quickly as possible without undue duress but in a safe manner. I will get to that later.

The amendments introducing this concept into the food and drugs regulations came into effect in July 1997 after thorough consultation and analysis in accordance with the regulations of the federal regulatory process. Members will notice from the dates that we are talking about something we have been exercising since 1997. It does not change the effect of the way we manage these things. It just brings it into the proper regulations according to the Standing Joint Committee on the Scrutiny of Regulations.

These provisions allow the director, defined as the assistant deputy minister of the health products and food branch of Health Canada, to issue a notice of interim marketing authorization to exempt certain foods from the application, in whole or in part, of the regulations after a thorough safety assessment has concluded that no harm will be caused to consumers or users. By doing so, the director can allow the sale of these foods by all manufacturers and producers while the regulations are amended. We do not have to go through this step for every manufacturer and every producer. Once this has been done, these products can go into the marketplace.

In fact, this is the final stage of the federal regulatory process and of the review conducted by the Standing Joint Committee on the Scrutiny of Regulations made by the governor in council, under the Statutory Instruments Act.

The standing committee examined the provisions on the notices of interim marketing authorizations and expressed concern that the power to exempt some foods from the requirements of the Food and Drug Regulations would give to the director administrative discretion that exceeds the legislative authority granted by Parliament to the governor in council.

Essentially, the standing committee maintains that the regulations authorizing the issuance of notices of interim marketing authorizations go beyond the scope of the Food and Drugs Act.

Since the coming into effect of these regulations, Health Canada has issued 82 such notices without any concerns being raised by consumers or the industry. Consumers have had quicker access to new and safe food products. For example, foods to which vitamins or mineral nutrients were added to increase their nutritional value were offered more quickly on the market.

It is important to understand that the committee's concerns are not related to food safety. Rather, they are technical having to do with the powers of health bureaucrats or personnel, under the act and regulations. This is what we want to correct. They are not making any comments, since this is not their role.

As to whether the system works, we have already issued 82 notices of authorizations without encountering any problems. We have been doing this for a while, following a public discussion process.

Moreover, the notices of interim marketing authorizations allowed for the quicker sale of foods from cultures that were treated with agricultural chemicals, including safe and effective pest control products.

In order to maintain the current mechanism that offers benefits to consumers and industry by allowing the consumer timely access to safe food products, the government has brought forward Bill C-28.

The first proposed amendment would provide the Minister of Health with the authority to exempt the food from the application, in whole or in part, of the Food and Drugs Act and the applicable requirements of the food and drug regulations.

The minister would do this by issuing an interim marketing authorization, which would allow the immediate sale of some food products for which scientific assessment has already established that these products would not pose a hazard to the health of Canadian consumers or users.

The sale of these food products would be allowed while the full regulatory process was undertaken to amend the regulations. It has to be clearly understood that all the questions of safety have already been taken care of and all the testing has been done; then we go through longer term regulatory process and the mechanics, which could take some time.

Just to stress this latter point, I repeat that the issuance of an interim marketing authorization would not affect or circumvent the conduct of a thorough safety assessment prior to the availability of these food products on the market.

These authorizations could only be issued when the scientific evaluation concludes that no harm to consumers would result from the consumption of the food, and Health Canada has made the decision to propose a regulatory amendment for a number of reasons: first, the extension of use of a food additive already permitted to be added in other foods into a new food or the change of a permitted level of use of a particular additive; second, maximum residue limits of an agricultural chemical or veterinary drug in a food where the food and drug regulations already permit these substances in other foods, or the increase in the permitted maximum residue limits; or again, the addition of vitamins, mineral nutrients and/or amino acids at different levels than those listed in the regulations, or to new foods.

This limited scope of application of the interim marketing authorization mechanism in the bill is exactly the same as in the current regulatory mechanism that was reviewed by the standing committee. The only difference is that it clearly specifies the authority in the Food and Drugs Act instead of the regulations.

Again, it is nothing new. It is giving stability to the industry and making sure that Standing Joint Committee for the Scrutiny of Regulations is comfortable and confident that what we are doing is within the regulatory powers of the department.

The second part of Bill C-28 deals with pest control products and their regulation pursuant to the provisions of the new Pest Control Products Act and the Food and Drug Regulations.

The new Pest Control Products Act, which was given royal assent in December of 2002, empowers the minister to specify maximum residue limits for the product or for its components or derivatives in food.

When specifying maximum residue limits, the minister shall evaluate the health risks of the product or its components or derivatives and determine if they are acceptable. To that end, he must determine that there is reasonable certainty that no harm to human health will result from use of a food item containing a residue level of a specific pest control product no greater that the maximum limit.

However, under the adulterated food provisions of the Food and Drugs Act and its regulations, a food is adulterated if it contains a residue level of a pest control product greater than the levels stipulated in the regulations.

Therefore, any food with a residue level of a pest control product not greater that the maximum limit set by the minister, under the Pest Control Product Act, cannot be sold until the maximum residue limit is officially set in the Food and Drugs Regulations. The regulatory change process can easily take up to two years.

The proposed amendment to the Food and Drugs Act to recognize maximum residue limits specified under the new Pest Control Products Act, for Food and Drugs Act purposes, would result in administrative efficiencies and would also benefit the agricultural industry by allowing faster access to improved pest control products for use on food crops.

The proposed amendments to the Food and Drug Act support the Speech from the Throne objective of providing a “predictable regulatory system that accomplishes public objectives efficiently while eliminating unintended impacts”.

They are also in line with the ongoing intent of the Government of Canada's smart regulation initiative and the recommendations from the external advisory committee on smart regulation. These aim in part to provide access to safe products in a more timely fashion and remove possible restrictions on international trade.

Finally, the proposed amendments will support ongoing work under the North American Free Trade Agreement technical working group on pesticides, through which Health Canada and the United States Environmental Protection Agency have accelerated bilateral harmonization in the registration of pest control products in order to provide faster and simultaneous access to a wide range of newer, safer pest management tools in both countries.

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Réal Ménard Hochelaga, QC

Mr. Speaker, my comments will be brief, which is unusual for me, although I do not exclude the possibility of expanding somewhat, if I feel any enthusiasm in this House.

Bill C-28 is a rather technical bill, as the hon. parliamentary secretary very eloquently reminded us. The purpose of Bill C-28 is to provide the Minister of Health with the authority to issue interim marketing authorizations. This is a bill reflecting the full extent of the will shown by the government to review the regulations.

As I said, the purpose is to enable the Minister of Health to issue interim marketing authorizations for foods that contain certain substances at specified levels, which are not hazardous to health, and therefore exempt from certain regulatory requirements for foods that have not yet been commercially approved.

We are not opposed to the principle of this bill. But I will be curious to see how it will be received in committee. In fact, I have just come from the Standing Committee on Health, where we approved a somewhat more controversial bill, on which I was pleased to work in a great spirit of consensus, a bill dealing with the whole issue of fire-safe cigarettes put forward by the hon. Parliamentary Secretary to the Minister of Health.

This study was undertaken in the previous Parliament. It is something to realize that, in committee, we have approved regulations drawing from the work of that precedent setting city of New York. In my opinion, it has to be one of the most beautiful cities in the world. l do not know how many hon. members have visited New York City during the Christmas period. Might I add that the people of New York elected their first female senator to the U.S. Congress? That is not the only thing that makes New York City an interesting place.

So, in principle, we support Bill C-28, which seeks to amend the Food and Drug Act. We will see just how far the minister wants to go in issuing interim authorizations. We understand that a number of criteria will have to be met. At first reading, however, we were not convinced that the minister was the best person to issue these interim authorizations. We will see what the Department of Health and the experts have to say in committee. This is a fairly technical bill, but we will do our work in committee as usual.

Personally, if I may say so on our last sitting day, I would have liked there to have been more work this session on the important issue of drug costs. This is an important debate that can create a welcome division of opinions. It is not always about agreeing on everything, since the right to dissent exists.

If I were asked to identify a few measures that this House could agreeably consider, I would spontaneously suggest four. First, it is not really acceptable, as the hon. member for Saint-Lambert knows, for the retail prices of generic drugs to be 30% higher in Canada than in the United States.

The United States is not, we agree, a society that opposes free enterprise. When I think that President Bush, a Republican, who is not a model for anyone in this House, is one of the most right-wing men I have never met, since I was denied access the day he came to the Hill. But it was not the right time to talk.

In my opinion, we must remember that the United States of America limited the scope of the Notice of Compliance, which was adopted in 1984 by the Conservatives, who wanted to establish various provisions to prevent counterfeiting. This was received favourably by some.

I remember, for example, that a man named Bernard Landry tabled a brief before the MacDonald Commission saying that it was important to have a national bio-pharmaceutical R and D industry.

We understood that the conditions were not in place for this industry to emerge when, from 1923 to 1988, anyone wanting to copy a drug—the parliamentary secretary knows this because he is very much on top of this question—could just pay a fee to the innovator. So a generic manufacturer wanting to copy a pharmaceutical product of an innovative manufacturer needed only to pay a royalty to the originator in order to do so.

At that point, there was not a lot of either legislative or regulatory control, but I can assure you that when the regulation was adopted, inspired by the U.S. legislation, the desire was to ensure that counterfeiting of drugs would be impossible.

There was some very real pressure brought to bear, both on the Government of Canada and on the governments of certain provinces, to adopt regulations similar to those in effect in the U.S. The objective of the link regulations was to avoid counterfeiting. While I do not want to stir up any unpleasant memories for anyone here, I would point out that the Conservatives under Brian Mulroney passed a link regulation in 1989.

What was this link regulation that was adopted under the patent legislation? The regulation provided that Health Canada could be blocked in the process of issuing a compliance notice if the same company filed a notification citing reasons to believe that a patent was about to be infringed.

Just to amuse my colleagues, I will take Viagra as my example. Viagra could have eight patents out on it, one for colour, another for the key ingredient, one for the secondary ingredient. So let us assume there is a total of eight patents. The generic company therefore has to go down the whole list of patents and prove that it is not going to infringe upon any of the patents for which a compliance notice has been issued

At the slightest hint of counterfeiting, the company that holds the first patent, generally an innovative company, can gain an injunction for 24 months. We know that, from the legal point of view, an injunction is a pretty potent thing—no bad pun intended there—a pretty serious thing, because the process will be held up for 24 months.

Hon. members need to know that this injunction is issued prima facie, and is a very drastic measure. The slightest allegation can block the process for 24 months.

If it were up to me to propose four measures, let us say, I think that this House should look at a better balance on the Patented Medicines (Notice of Compliance) Regulations. The Patented Medicine Prices Review Board has the same powers as a superior court. It limits the prices set by manufacturers for all patented medicines to ensure they are not excessive. In Canada there is control over medicines, but not a limit on the retail price. That is not what we are talking about. This is control linked to the cost of medicines from the moment the manufacturer puts them on the market until the time the Patented Medicine Prices Review Board has a look at them.

Thus, the Patented Medicine Prices Review Board Act could be amended to ensure that the generic manufacturers are also subject to it.

Third, in addition to asking questions about the Patented Medicines (Notice of Compliance) Regulations, and hoping for changes in the Patented Medicine Prices Review Board, I think we all know that Canada is participating in an international conference on data harmonization.

Of course, we can easily imagine how thrilling a quest for learning this must be. Canada is therefore an observer at an international conference where Japan and the European Union are represented. Should we not be looking at mechanisms for making drug approvals easier?

Should we not be asking questions, as parliamentarians, about the way we want the companies to present their clinical data? Let us not forget that there are usually three phases in getting a notice of compliance. In each phase, clinical data must be presented. Naturally, this can cost thousands of dollars.

In short, with respect to the cost of medicines, we must look at the issue of the PM(NOC) Regulations, the role of the Patented Medicine Prices Review Board, and the way this can be done as quickly as possible. It is in the public interest, so that Canadians and Quebeckers can have access to medicines and know they are safe. It is a matter of health and public safety to make certain that the medicines for which a notice of compliance is issued will not be subject to a recall.

Unfortunately, over the past few weeks there have been three examples of drug recalls. That is not good. There needs to be a good balance between quick and careful registration and there also needs to be mechanisms that give reasonable and solid guarantees on the safety of the drugs.

I know that in the previous budget the government had announced an extra few million dollars to help Health Canada perfect its analysis techniques. When a clinical monograph is submitted it can represent a stack of books from this wall to that wall. I am talking about thousands of pages of information that has to be looked at by examiners, who are often doctors, people who have a doctorate who must fully understand—research drugs are first tested on animals and then humans—the entire framework of the clinical trials.

If the parliamentary secretary does not mind, I will digress a little and talk about something that is at the heart of Bill C-28. The issue of clinical trials in Canada is a bit slack. We looked at this in the parliamentary committee. There are no real regulatory agencies that monitor clinical trials. Health Canada does this a little, somewhat horizontally. This issue of clinical trials is an extremely important one. It poses ethical questions as well as medical questions.

In the parliamentary committee, we presented 15 or so recommendations to the Minister of Health so that Canada could become competitive in terms of the conduct of clinical trials and also so that these trials could be publicly funded. It is unsettling to see that most clinical trials in Canada are conducted at the instigation of the private sector. Very little publicly funded research has been done on clinical trials. One has to wonder: is it good, in a society like Canada's, for the pharmaceutical industry to dictate, in a way, the clinical information program? I am not so sure. I think a solid research infrastructure needs to be implemented.

I want to digress again. We have, of course, the health research institutes. We do have to recognize that their budgets are now over half a billion dollars.

I have very fond memories of the time I spent as R and D critic for my party. The following will recall those fond memories for the House.

The former premier of Quebec, Mr. Bouchard, is a brilliant lawyer and a first-rate litigator. He was a remarkable premier, a strong statesman, who served Quebec very well. I am being, of course, very objective here. Let me remind my hon. colleagues of the brilliant campaign we led in 1993 under Mr. Bouchard, who was the leader of the Bloc Québécois at the time, which turned us into the official opposition.

In a huge fit of generosity, rarely seen in public life, Mr. Bouchard entrusted me with the R and D portfolio. That kind of surprised me. As people close to me know, I am a noble-hearted man, who has a very tough time operating a VCR. So, I was not too familiar with research and development. But I certainly tacked it. I met with people and read a lot of reports.

At the time, there was no department dedicated to research and development. I was very surprised then to read a report from the OECD, which, in a way, is the rich countries club. During the 1990s, the OECD was saying that Canada was next to last in research and development. This is serious. A continental country such as Canada, which had a relatively high GNP, was focussing less on research and development than other nations that had much fewer resources.

At the time, the industry was bitterly complaining about this situation. Some leadership should be assumed through public funds for research and development. We should not think that this is merely the responsibility of the private sector.

I will conclude this digression by saying that we have witnessed the creation of 13 Canadian institutes of health research, which basically replaced the medical research council of Canada.

The council was well known to Quebec researchers. During at least one generation, particularly when Mr. Bureau provided leadership with the health research funds for our province, on average, Quebec researchers were presenting 33% of the applications for funds to the medical research council of Canada. Even though we accounted for only 24% of the country's population, our ratio of researchers was much higher. Consequently, we were hoping to get corresponding funds.

When we examined the research by the Canadian institutes of health, we found out that they were virtual. Consequently, we were funding researchers and infrastructures, but these were not physical locations. We wanted networking for each of the research centres that existed at the time. We had an institute of health research for neurology, another one for cancer, and yet another one for mental health.

Concerning mental health, I want to digress for a moment. In the next years, one Canadian in five will have various degrees of mental health problems. Our relationship with mental health will thus face a major challenge in the next years. In a society where there is a lot of stress, health determinants vary.

It is interesting to ask ourselves why a person may go through life with a healthy attitude, a good mental balance, even a certain joy of living. We realize more and more that it is not medication that contributes to this. Tobacco use, among other things, has some effect on this.

In conclusion, we will study Bill C-28 in committee. It is a technical bill, but we realize that it has a lot of substance. We will be happy to hear representations from officials. We have some concerns over the role that the minister might want to take upon himself in respect of voluntary notices of compliance. We will be vigilant, but we view favourably a bill that I have examined thoroughly.

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West Nova
Nova Scotia


Robert Thibault Parliamentary Secretary to the Minister of Health

Mr. Speaker, I do not know exactly where to start in putting my question. The hon. member and Bloc Québécois critic for health started off by saying that he would be brief. By that he meant that he would touch only briefly on the matter at hand and spend all his speaking time on several issues, each more interesting and more important than the other.

He raised all at once clinical trials, horizontal application and Viagra. Bearing in mind the time of day when our proceedings are broadcast on television across the country, perhaps we should be careful with that.

Regarding Bill C-28, I am pleased to see that we can count on cooperation and discussion at committee. The hon. member and all the other hon. members will recognize that the intent is to institutionalize what is already in place, what we have already been doing for the past five or six years, and that we are responding to the request by the Standing Joint Committee for the Scrutiny of Regulations. We must therefore make sure that the regulations we apply will not be successfully challenged in court.

I would like to come back briefly to tobacco use. I want to congratulate the Parliamentary Secretary to the Minister of Finance, who raised the issue. We considered it today at committee and heard testimonies. All members of the committee unanimously approved a report.

It is indeed important to have this discussion today because, this evening, the hon. member for Cape Breton—Canso will be introducing a bill concerning a deduction for volunteer emergency service workers and the contribution they make to Canada when it comes to curbing among Canadians the risk of fire associated with tobacco use. That is very important.

I would also like to congratulate the hon. member, as well as the hon. members of all stripes who sit on the committee. We have done good work on the quarantine issue. We have moved the issue forward and demonstrated that a minority government can work, take action and count on the cooperation of everyone. These were my comments.

I would like to thank the hon. member for his cooperation with respect to Bill C-28.

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1:30 p.m.


Réal Ménard Hochelaga, QC

Mr. Speaker, you will have noticed, as I did, that the Parliamentary Secretary to the Minister of Health started with Viagra and finished with thanks. However, I would also be remiss if I did not mention the very good work that he has done in committee.

As a matter of fact, this is developing our taste for a minority government. Indeed, if all committees and parliaments had worked the way we are working now and had considered everyone's opinion, it would have been interesting.

Indeed, what is interesting about the situation of a minority government is that the government has to work more cooperatively with all political parties. What is interesting in the Standing Committee on Health is that all opposition parties, like the government, have had their amendments agreed on and, of course, these were highly relevant amendments.

Concerning smoking, of course I share the minister's elegantly euphoric enthusiasm about the adoption of regulations on fire-safe cigarettes.

I hope that we will be able to rely on the minister and on another matter which, although not directly related to health, is not totally unrelated, that is the brilliant suggestion by the member for Charlesbourg—Hate-Saint-Charles to change the gay marriage legislation to also allow for divorce. I believe there is a link here with health. The health determinant must encourage us to make links. All this is encouraging us to prepare for the agenda of 2005, which will be a fertile year.

Once again, the key word in this parliament must be government: cooperation with the opposition. In a minority government, the government gains in stature from its cooperation with the opposition. We are in a period of our collective history where the main characteristic of the opposition is its eminently reasonable, serious, forward-looking, perceptive, dogged nature and, of course, its relevant judgment and amendments.

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1:35 p.m.


Robert Thibault West Nova, NS

Mr. Speaker, from what I understand, the hon. member for Hochelaga is saying that the ideal thing would be to have a Liberal majority government that acts like a minority government.

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1:35 p.m.


Réal Ménard Hochelaga, QC

Mr. Speaker, of course I understand how the parliamentary secretary feels about his political party. We cannot hold that against him. However, the ideal solution, the one that would better serve the interests of Quebeckers and Canadians alike, would be based on cooperation where, in committee, the amendments brought forward by the opposition would be agreed upon in order to enhance bills that would hopefully serve the public interest.

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1:35 p.m.


Gurmant Grewal Newton—North Delta, BC

Mr. Speaker, I am pleased to rise today on behalf of the constituents of Newton—North Delta and the official opposition of Canada to participate in the debate on Bill C-28, an act to amend the Food and Drugs Act.

This enactment would amend the Food and Drugs Act to provide the Minister of Health with the authority to issue interim marketing authorization for foods that contain substances at specified levels, and to exempt those foods from the applicable requirement of the act and its regulation relating to their sale.

The proposed amendments are in response to concerns raised by the Standing Joint Committee for the Scrutiny of Regulations regarding an administrative process put in place by Health Canada under the regulations of the Food and Drugs Act to allow Canadians faster access to food products under specific circumstances. All members of the House want our food supply to be safe, efficient and effective.

The bill proposes to amend the Food and Drugs Act to achieve two purposes. First, to provide the Minister of Health with the authority to issue an interim marketing authorization for the early sale of safe food and safe food products that contain certain substances; and second, exempt any food that contains an agricultural chemical, at or below the maximum residue limit specified by the minister under the new Pest Control Products Act, from the prohibition in the Food and Drugs Act of the sale of foods containing these residues because the sale of these foods would not pose harm to consumers. We are talking about safety.

The bill would give the minister authority to issue interim marketing authorization for food products wishing to enter the market earlier or that have previously entered the market and have added or modified contents since initially approved by Health Canada.

Currently, the deputy minister of health responsible for health products has the authority to issue interim marketing authorization, IMA. The minister is arguing that the authority to issue the IMA is a power of Parliament granted by the Crown and therefore the responsibility for the IMA should rest with the minister.

The bill would also allow for food products which contain pesticides, veterinary pharmaceuticals or added vitamins, minerals or amino acids at or below the maximum residue limit to be exempt from the FDA regulations while in the approval process.

Briefing material provided by Health Canada argues that Canadian companies are currently at a great disadvantage because of the lengthy approval time for new or modified food products. Canadian companies are not on a level playing field with their trading partners, particularly in the American market. This is because the U.S. government allows food products in the approval stage to be marketed, given that they are not harmful and not restricted by any other law or legislation.

The amendment that we are debating would put Canada on a par with the United States and give our food producers a level playing field when it comes to new products entering the market.

We would not be here today were it not for the Standing Joint Committee for the Scrutiny of Regulations. Bill C-28 is a direct consequence of concerns first raised by that committee in April 1999. At that time, over five years ago, the committee identified the regulations of the Food and Drugs Act permitting interim marketing authorization as illegal. In other words, it was not supported by legislation.

Much of the law that affects Canadians is not found in the statutes of Canada, but in the thousands of regulations made pursuant to powers granted by acts of Parliament. Each year the federal government introduces about 1,200 new regulations. Since 1975 the federal government introduced over 28,000 regulations. That is 122,000 pages of regulations. About 20% of the laws in the country stem from legislation debated and passed in this legislature. The remaining 80% of the laws that we see are made up of regulations; just 20% is what we passionately debate in the House.

After a debate, we vote yea or nay, depending on the merit of the proposed law. The media and the general public focus on the 20% component. However, the 80%, which is coming through the back door by way of regulations, is not debated nor are other parliamentary democracy principles applied to those regulations.

Regulations on the other hand, receive virtually no debate in the House or even the other place, no public policy input, no studies or media scrutiny. This is an affront to democracy. Under parliamentary reform, this is the one the main issues at which we must look.

My private member's Bill C-205 passed in the House. I thank all members for their support. What will the bill do? We all know the government rules, but does not govern through the complete parliamentary democracy and practice. Some 80% of the regulations, which comprise the law, are made under the authority of Parliament. Various agencies, bodies or quasi-government organizations are delegated the authority to make regulations. However, when they make regulations, Parliament does not have the authority to scrutinize or review those regulations.

Therefore, a big chunk of our laws have been completely ignored. There is a big black hole in accountability and democracy which has been ignored for so long until Bill C-205 passed. With the passing of the bill, Parliament now has the authority to review regulations of those agencies through the Standing Joint Committee for Scrutiny of Regulations. They will now be scrutinized and if need be, disallowed.

My bill restored some of that democracy. It was a huge step in parliamentary reform. We talk a lot about reform, but little action is taken.

The Standing Joint Committee for Scrutiny of Regulations does the only scrutiny. Very limited scrutiny of regulations is done in Parliament. Our new regulations are permanently referred to the committee pursuant to the provisions of section 26 of the Statutory Instruments Act. Members of Parliament and Senators are on the committee. Legal counsel and staff work diligently, scouring through thousands of papers on dry, technical, legal subject matter as part of their thankless task of reviewing regulations.

This committee is generally misunderstood and ignored. This committee is considered to be not a very high profile committee, despite the hard work it does. In fact, talking about parliamentary democracy, this committee should be considered a very important one. It is an essential watchdog, protecting democracy, controlling bureaucracy and holding the government to account.

The standing joint committee does not judge regulations on the basis of policy measures, general merit, or necessity. Its study of regulations is instead limited to the questions of validity and legality. Members follow uniform and clearly defined criteria in their examinations. Compared to most committees, this committee is non-partisan and we build consensus in the committee.

The committee judges whether or not an statutory instrument: is not authorized by the enbabling legislation or is not in compliance with the conditions set forth in the legislation; does not conform with the Canadian Charter of Rights and Freedoms or the Canadian Bill of Rights; purports to have retroactive effect without express authority being provided by the enabling legislation; imposes a charge on public revenues, imposes a fine or imprisonment without express authority; excludes the jurisdiction of courts; has not complied with the Statutory Instruments Act with respect to transmission, registration or publication; appears to infringe on the rule of law, trespasses unduly on rights and liberties, make rights and liberties unduly dependent on legislative discretion, makes some unusual or unexpected use of powers conferred by the enabling legislation; amounts to the exercise of power that should properly be the subject of parliamentary enactment; and is defective in its drafting, including the translation.

These criteria deal with matters of legality and procedural aspects of regulation, not the merits of the regulations or policy.

The committee works meticulously, and with the complex nature of its undertaking, work proceeds at a slow pace. The long delays in dealing with particular items are largely related to the large number of regulations which the committee has to review relative to the number of meetings it can hold each year. All this considered, the committee, with the able assistance of its long-time legal counsel, Mr. Francois Bernier, is remarkably productive. Consider that over the period from November 7, 1997 to December 6, 2001, the committee dealt with 1,133 pieces of subordinate legislation in the course of 45 meetings.

I am a seven term co-chair of the Standing Joint Committee on Scrutiny of Regulations, representing all members of the House and I speak from personal experience. The work of the committee members can be extremely frustrating. We in effect hold ministers accountable for the legality of subordinate legislation, primarily regulations, sponsored by their departments.

However, this task is at times almost impossible. When the scrutiny of regulations committee finds a regulation that it deems in conflict with the legislation, our first step is to inform the respective department in writing. It should be a simple process. We identify a problem regulation, inform the department and then it fixes it. Instead, what we usually encounter is foot-dragging that can carry on for years or even decades.

The Food and Drugs Act regulations are an example of this foot-dragging. For five years, the department argued that there was nothing wrong with the regulations concerning the notice for interim marketing authorization. We are debating this today. Finally, after so many years, the department abruptly informed the committee last April that it was proceeding with the legislation before the House today. For over five years, the department has been using illegal regulations. Those are the regulations we are trying to correct today.

In a democracy that prides itself in the rule of law, this is unpardonable, but it is not the least bit unusual. Recently, my committee finally closed another file that had been opened for 27 years, more than a quarter of a century.

The committee's usual practice is to deal with a problem regulations informally by letter to the relevant officials. This allows the minister involved to amend the regulation with minimum fuss. The committee can also prepare and issue a disallowance report, but this is usually done only after the department has failed to address our previously identified concerns. Disallowance reports are very rare.

Let us consider the sequence of events surrounding the Food and Drugs Act regulations concerning interim marketing authorizations. I want to give this example so that the members in the House, the public in general, and our media scrutiny can also understand and comprehend the problems facing this committee.

On April 7, 1999 counsel for the scrutiny of regulations committee wrote to the DIO and questioned the legality of provisions of food and drug regulations that provided for notices of interim marketing authorization. The objection was that these provisions provided for unauthorized exemptions and also involved an illegal sub-delegation of powers.

On November 25, 1999, 232 days later, the department responded that it considered the provisions to be a valid exercise of regulation-making powers conferred by the Food and Drugs Act.

On December 23, 1999, the committee counsel reviewed the arguments put forward by the department and sent a letter countering those arguments, asking for reconsideration.

On March 8, 2000, now 355 days, almost a year after the initial correspondence and over three months since the last letter, the department replied indicating that generally it was committed to the policy, but that it might review the regulatory provisions in question with a view to making a “clarifying amendment.”

Exactly seven months later, on September 28, 2000, the committee was forced to again write to the department to inform it that it wished a detailed response to its letter of December 23, 1999.

Nothing more was heard from the department until October 17, 2001, over one year since the last correspondence, when a comprehensive reply to the letter of December 23, 1999 was finally received by the committee.

On December 12, 2002, the file was re-submitted to the joint committee with a 13 page note on the October 17, 2001 response.

On March 3, 2003, myself, as co-chair of the standing joint committee, wrote to the Minister of Health to restate the committee's position and explain why the response from the department was not accepted.

Over a year later, on June 24, 2004, the committee was informed that:

It is the intention of the Department to bring forward legislation in the early Fall 2004 that will amend the Food and Drugs Act to allow the Minister of Health to issue NIMAs and provide for a limited power to exempt food products from the application of the Food and Drug Regulations and paragraph 4(d) of the Act.

Finally, on November 29 Bill C-28 was introduced. There was a little over five years between the time the issue was first raised with the department and the introduction of remedial legislation. As I said earlier, when compared to other files that stretch on for decades, this issue was resolved rather quickly. However, five years is still five years. That is far too long for illegal regulations to remain in place.

Departments and their ministers take far too long to respond to concerns of the committee. There is no good reason for the department to go over a year without responding to a letter from the committee. It is an affront to the rule of law, it is an affront to Parliament and it is an affront to democracy. That is why we need Parliament to be reformed, including scrutiny of regulations issues.

I support Bill C-28. The amendments to the Food and Drugs Act are years overdue. I give full credit to the members, the staff and the counsel of the Standing Joint Committee for the Scrutiny of Regulations for identifying the drawbacks in the system, bringing that to the fore, and following and chasing it through until remedial action is taken by the department to correct this parliamentary affront that has been going on so long.

I will conclude by asking members of Parliament to look into the regulatory process so that the regulatory process in this country is fair, efficient and effective.

Food and Drugs Act
Government Orders

1:55 p.m.


Paul Szabo Mississauga South, ON

Mr. Speaker, I welcome the member's comments on this. It is an issue that has been with us for decades, actually, this issue of legislation in fact being made through regulations rather than through Parliament. It really is the governor in council making laws.

In this case, as the member has laid out, the issue is more about expediting the timeframe between a decision being taken and getting a product approved for use. As I think the member pointed out, there have been over 80 interim authorization orders executed and there has been no adverse feedback from any of the stakeholders.

In that regard, is that the member's understanding? Is this a mechanism or the model whereby regulations are in fact further seconded down to a fast track? Is that not an area which the member would consider to be a further risk element to having legislation being done through regulations or interim authorizations?

Food and Drugs Act
Government Orders

1:55 p.m.


Gurmant Grewal Newton—North Delta, BC

Mr. Speaker, in the first instance, I think it is a serious concern for all members in the House when some regulations are contradicting the authority given by legislation. Second, safety and security are at risk in many issues when the departments are dragging their heels and not dealing with the issue.

In general, I think we have to work a lot in this place on regulatory reform. There are many regulations that overlap and duplicate. In various departments, some of the regulations completely contradict each other. They need to be taken care of, and as well, I think harmonization of regulations is a serious issue.

The government has been dragging its heels on the harmonization of regulations, even with our largest trading partner, and even in east-west trade that is taking place in our country from province to province. There is a lot of overlap and duplication. Harmonization is needed to correct those mistakes.

I will say that as a first step we could identify the regulations and put them in three categories: good, bad and ugly. We need to keep some good regulations, which ensure safety of food, protection of the environment and provide us with security, but we need to get rid of the ugly regulations, which should not be in place.

I think regulatory reform becomes an integral part of parliamentary reform, about which there has been a lot of talk but little action.

I take some credit for this for having my bill, Bill C-205, pass in the House. That is not a very common occurrence. It is very rare that a private member's bill becomes law. It brought various regulations by various quasi-government agencies and organizations under the umbrella of Parliament. It restored parliamentary democracy and accountability to a great extent. It did plug the regulatory accountability black hole that had existed for so long.

I believe that Parliament should take the direction of bringing about regulatory reform as an integral part of parliamentary reform so that such issues are dealt with more effectively and efficiently.

London Knights
Statements By Members

December 14th, 2004 / 2 p.m.


Sue Barnes London West, ON

Mr. Speaker, it gives me great pleasure to pay tribute in the House today to the London Knights of the Ontario Hockey League. Their 0-0 tie with the Guelph Storm last Friday night set a new Canadian Hockey League record of 30 straight games undefeated. Sunday's overtime win against the Kitchener Rangers extended the unbeaten streak to 31 games.

This surpasses the 1978-79 record of 29 games without a loss, previously held by the Brandon Wheat Kings of the Western Hockey League.

This is a remarkable accomplishment for the Knights. I am proud to have been among the thousands of fans at the game to witness this historic event. I know that some other colleagues from the House were there also.

I wish to extend congratulations to all the team members, as well as the president and head coach, Dale Hunter, and vice-president and general manager, Mark Hunter, for leading such a well-rounded and disciplined hockey team.

I know that all members of the House, especially my London colleagues, will join me in congratulating the London Knights as the CHL record holder for the most consecutive wins. I say keep going, Knights, and well done.