February 20, 2004

PC

Loyola Hearn

Progressive Conservative

Mr. Loyola Hearn

And accountable, and if proper assessments have been done on the individuals involved.

We have seen some horror cases in this country in recent years where people who were let out on parole have quickly offended. The sorrowful thing is that in almost every case, somebody in the system said that they knew, they warned people, and they had concerns that these people would offend again.

We have concerns as well. The former speaker said we must clarify who the victims are in this case. That is certainly true. We must know the victim and we must ensure that the victim is looked after. I believe the real victims in this overall scenario are the people of Canada because they have been victimized left, right and centre by the government opposite.

If we were here today as a parole board and we were asked if we would let the Prime Minister and his cabinet out on day parole, or parole at all, to mingle among the people of Canada and to make major decisions affecting the lives of Canadians, that would be interesting. Maybe, Madam Speaker, if we want to kill a few more minutes, you could have a straw vote here just to see how many would really turn the Prime Minister loose on parole to deal with the issues facing Canada. The proof of the pudding is in the eating. That is an old saying from Newfoundland and certainly right across the country. We have seen the proof of the pudding.

The government has been in place for four years. The Prime Minister has been around all that time. He was in the most important position to bring into effect changes in this country. He was the finance minister. What is the result? What are we seeing being done to address the real problems in this country? What are we seeing besides platitudes and procrastination? We are seeing absolutely nothing.

It is time we change, and not only this bill. Hopefully, we will get the chance to make the proper changes here but more so, let us hope that Canadians will get the chance to make the changes they want made.

Topic:   Government Orders
Subtopic:   Corrections and Conditional Release Act
Permalink
LIB

John Godfrey

Liberal

Hon. John Godfrey (Parliamentary Secretary to the Prime Minister (Cities), Lib.)

Madam Speaker, I would like to thank the member for St. John's West for his remarks.

This is, despite anything suggested to the contrary, an important piece of legislation. It is not a trivial matter. The hon. member has accused us of killing time and that this debate is irrelevant. I suppose if that were the case, I might congratulate the hon. member for joining in the spirit of the thing.

I found the connection between the subject under discussion, amendments to the Corrections and Conditional Release Act and the state of the east coast fishery, incredibly creative. It was a line I had not heard before, but I want to commend him for his creativity.

It is important to return to the essence of the matter, which is the whole question of crime and punishment in this country and how we deal with it. It can be said that the prison system is a reflection of society's failures. It is what happens to people when we do not get it right, when we fail to make and create high functioning citizens.

I have some experience with the prison system because in the 1970s, as a young professor of history at Dalhousie, I used to spend time visiting young students who were inmates in Springhill Penitentiary. I have some personal knowledge of the complexities of issues surrounding crime and punishment. The impression I took away was that these were very complex issues.

We are examining why it is that people do dreadful things to each other, and why is it that we fail as human beings and have to be punished? The question for us as we contemplate amendments to the act is, how do we test our own civilization and how do we protect our own civilization? How do we get the balance right, as the member for Burlington suggested?

How do we treat people in our society who fail, people who are vulnerable, while we protect other people's rights? How do we measure our civilization in terms of protecting their rights when they have often taken away the rights of others? These are the difficult questions which surround the way in which we treat people when we send them to prison and then decide when to let them out, and when it is that we can trust them to be integrated back into society.

It is interesting that the amendments which we are discussing were actually recommendations made by the Standing Committee on Justice and Human Rights. In our system, justice and human rights go hand in hand. Everybody's human rights must be protected, even the rights of people we do not like very much and who have done bad things.

That is why we have provisions in this bill regarding the accelerated parole review process. We are trying to get the balance right again. We are trying to ensure that people who are capable of rehabilitation will be rehabilitated. We are trying to ensure that we protect society from those who will reoffend.

These are very difficult judgment calls. What determines the outcome of that is often a consequence of what we do for people while they are in prison, whether we can actually help them prepare for a life beyond prison. Many people in prison do not have much education. They have been denied the breaks that the rest of us have had.

Another important component in this set of amendments is the requirement for Correctional Service Canada to review all offenders who are entitled to statutory release for possible referral to detention or the imposition of special conditions. Once again we are balancing off the rights of prisoners with the rights of all of us to be safe in our communities. A very tough call and one which requires tremendous attention.

I know from my experience with the prisoners of Springhill when the importance of temporary absences was a major issue. How does one reintegrate people into society from what is an incredibly protected environment? There is something quite strange about prison. People actually go in to some unreal place, which is not at all like the world we live in. In fact, they lose whatever skills they had in society and so, upon release, they have to get used to society bit by bit.

I can remember, as a young professor of history, in the college where I was teaching, young prisoners coming with their parole officers to get used to the idea of being reintegrated with people of both sexes, of all ages and of all backgrounds.

What we do with temporary absences is incredibly important. We must ensure we know what the rules are. We must clarify the decision-making authority and we must be more purposeful about why we have temporary absences. We must socialize these people. They will be joining us in a better state or a worse state, but they will eventually get out of prison, except if they are there for life.

In this difficult task of balancing everybody's rights, we must hear from the victims. It is really important that we take into account their rights to be present at a Parole Board hearing to say why it is that this person should not get out or what it is that this person has done to them and their family. That is part of natural justice and must be brought to bear.

It is also important to recognize, as my colleague pointed out, that there are, among the prison population, older people, people who have fallen ill and who will not in the normal course of events survive to come out of prison. As human beings we must respond to those illnesses and difficulties. We must let them out to die in some kind of dignity, recognizing that they may have denied that dignity to somebody else. That is a tough call for all of us as human beings.

Topic:   Government Orders
Subtopic:   Corrections and Conditional Release Act
Permalink
?

The Acting Speaker (Mrs. Hinton)

It being 1:30 p.m., the House will now proceed to the consideration of private members' business as listed on today's Order Paper.

Topic:   Government Orders
Subtopic:   Corrections and Conditional Release Act
Permalink
CA

Rob Merrifield

Canadian Alliance

Mr. Rob Merrifield (Yellowhead, CPC)

moved:

That, in the opinion of this House, the government should consider making it mandatory for health care professionals to forward to Health Canada information on all “serious” adverse drug reactions within 48 hours of their occurrence.

Madam Speaker, it is a pleasure for me to be able to introduce a motion in the House. It is a very important issue because it needs to do two things. We need to raise awareness of a very serious problem in Canada, something I have had a researcher on for the last three years. It is something I have a tremendous amount of information about and we have seen a lot on about it on the CBC news this week with its reporting of exactly what is going on. Canadians are starting to wake up to the issue and this is an attempt to wake the House up to this issue and actually do something about it.

Not only do we need to raise awareness, but we also need to make sure that we put into law the awareness we are trying to raise of the number of adverse drug reactions. We actually must have mandatory reporting of those serious adverse reactions from our professionals in the health care system, our doctors, nurses, pharmacists and other health care workers.

It is important that we raise awareness of these issues. The CBC has done a very good job of that. Actually it has tried for the past five years to get information on the database that Health Canada has with regard to the number of adverse reactions that are being reported in the country. The CBC was able to get this information only through an access to information request. Now they have 162,000 recorded cases on a website, so Canadians from coast to coast to coast will be able to go to the website to try to determine this and see for themselves some of the reactions that are happening.

It is very important because we see skyrocketing numbers of cases in Canada. Some of the numbers disclosed this week involve kids. Serious reactions in that group have tripled in the last couple of years, but Health Canada has no ability to be able to deal with trends for this information.

That is another thing that has come forward. Even if Health Canada had all the reporting in place right now, we have to understand that it does not have the wherewithal to be able to deal with the actual trends taking place before our eyes. It is understaffed and underfunded. Not only are we going to have to be able to deal with awareness and mandatory reporting, but then we have to deal with what we are going to do with that information and how we are going to protect Canadians because of it.

In March 2000, this all came to a head when Vanessa Young, a 15 year old girl from Oakville, died in front of her father because of the inappropriate use of a drug called cisapride, also known as Prepulsid. The two names mean the same drug. Health Canada knew about this back in 1996, long before this child died, and the United States had flagged it as well. There were 14 deaths from this drug in Canada prior to this time and numerous other deaths in the United States. Why was it allowed to happen in Canada before our eyes? Why is it happening today? We have to ask ourselves those questions.

The coroner's inquest actually brought this to light. There were actually 59 recommendations coming out of that inquest as to how we could deal with the problem, 14 of them levelled right at Health Canada. One of them was the mandatory reporting of adverse or very serious reactions to medication within 48 hours. Therein lies what this motion is all about, which is to make sure that this actually happens.

In fact, the inquest went one step further and actually defined what “serious” means. It means that which results in “significant disability or incapacity, is life-threatening or results in death”. It is a very clear, very simple definition of exactly what we are talking about.

We have to ask why this was not acted on before now. Why is Health Canada dragging its feet on this one? This is not the first time that this idea has been introduced in the House. There was another very similar motion introduced by the member for Winnipeg North Centre in September 2001. At the time it was introduced to the House, it was discussed and supported by all sides of the House. One would have thought that would send a serious message to Health Canada but it did not, because there was no vote on it and no actual direction from the House to make sure it would take place.

So now we are seeing a much more serious problem as it escalates. We have an opportunity to send a very serious and very strong message to Health Canada and to the Minister of Health so that we will be able to deal with the issue.

How big an issue is it? How big a problem do we actually have out there? I think we need to ask ourselves that.

A study done in the United States in 1998 estimated that, annually, 2.2 million individuals were hospitalized for serious adverse drug reactions. There were an additional 106,000 fatal adverse drug reactions in that same year.

We can compare the data. There are 300 million people in the United States and 31 million in Canada. That translates into a little over 10,000 deaths in Canada on a yearly basis due to adverse drug reactions. These are significant numbers. A 1999 report in the Canadian Medical Association Journal estimated that there were approximately 1,825 deaths due to adverse drug reactions. The doctors themselves came forward with these numbers. Researchers David Rosenbloom and Christine Wynne estimated that the number of deaths due to adverse drug reactions was around 7,600.

The numbers are all over place, but just using those numbers, adverse drug reactions translate into being the seventh leading cause of death in Canada. That increases the number of days for a hospital stay to 4.6 days more per individual and costs our health care system about $300 million annually.

We can play with the numbers all we like, but it does not really matter how big we make them. We have to understand that the numbers are really there. In fact, Health Canada said that in 2001, 54,000 Canadians experienced adverse drug reactions. That would translate into about 3,800 people who died in that year.

We have to say, then, that this is a very serious problem and it is getting worse all the time. Why are professionals not reporting adverse reactions? The number of reported incidents is estimated at somewhere between 1% and 10%. Why is that? We have to understand the stress that some of our physicians are under right now. There is no incentive for them to do so. A lot of them do not even know where the form is to report adverse reactions, and it is a lengthy form. We have to look at some of the solutions to this.

This is not about attacking physicians. This is not about attacking professionals. This is not about attacking pharmaceuticals. This is about bringing awareness to the issue and then looking at how we are going to deal with it.

Whether it is 400, 4,000 or 10,000 deaths is probably not really the issue. We have to understand that every one of those deaths translates into real people, real families and real friends, and every one of those deaths was preventable. If they were not preventable, they should have at least raised a flag so the same mistake could not happen to any other individuals. We owe at least that to those who fall victim to adverse reactions.

Where do we go from here? Why should we have mandatory reporting? Because we see the amount of drugs being used in this country. In 1992 Canadians spent $8.5 billion on pharmaceuticals. In 2002, a decade later, Canadians spent $18.1 billion. That is a $10 billion per year increase. With those kinds of numbers and the amount of drugs being used, we have to say that we have a serious problem and it is going to get worse.

The baby boomer generation is now closing in on 55 to 65 years of age and the consumption of medication is going to increase. We have to deal with the problem now. We have not seen anything yet when we realize what is coming down the road at us.

Let us get serious about this problem. Let us get serious and do something about it. We need mandatory reporting of pharmaceuticals by doctors, pharmacists, health care professionals and consumers. That is one way we can help this situation along.

This is not the first time a flag has been raised in Canada. Colleen Fuller is an individual who fell victim to an adverse reaction and became interested in doing some research on this. The Krever inquiry also raised a flag about mandatory reporting of adverse reactions. Vanessa Young's coroner's jury is another example.

Not only that, Canada's Auditor General said in a report in December 2000 that we cannot get to the bottom of the actual numbers and know what is going on because reporting is not mandatory. It is just voluntary. If it is just voluntary, then we do not know what the numbers are.

As I said before, only 1% to 10% is actually being reported, so there is a 90% error and guesswork is going on around this whole issue. We have to do something about it.

It is absolutely critical that we get serious about dealing with this issue. We also have to ask why it is not happening, why it is that the reporting is not going on. We have to realize what our physicians and nurses are dealing with. They have two of the most highly stressed jobs in the country. In fact, the sickest workplace we have in the country is our hospitals. Our nurses are stressed to the max. They take more sick days than any other occupation, any other professional group of individuals. When it comes to doctors, we understand that 75% of them are refusing to take on more patients because they are so stretched and so worked to the max. This is not an attack against them. This is an attempt to be able to give them the tools to be able to deal with this in a more appropriate way.

Why are they not reporting it? Number one, they have no incentive. They have no time. Family practitioners are only paid for a 10 minute visit.

We have to give them some of the tools. Maybe we do not have to use a long form. Perhaps we could use BlackBerry technology or another reporting system that could give them the ability to report in a way that is not cumbersome, in a way that is streamlined so they can do it. We have to engage them in that process. We have to ask them how they would like to be able to come forward with mandatory reporting and how we can work collaboratively with them.

That is where we need to go with this motion. This makes it mandatory, but it does not bring forward the actual tools so that we are able to do it. That is why I did not bring forward a private member's bill, which would bring down the specifics. What we want to do is raise awareness, engage in debate, and give a direction from the House that we will not take it anymore, that Health Canada has to act, and that we have to make sure something is done for the betterment of our citizens.

It is also not an attack at all against the drug companies. Many of the medicines that we use are wonderful technologies. They do a great amount of good, but there is also a great amount of harm. We know that. Some of the information from research I had been doing in my own office pointed me to some of the problems that are going on in this country, so we initiated a study that was done by the Standing Committee on Health. We travelled from coast to coast this fall dealing with the pharmaceuticals and the adverse reaction to these medications. Some of the testimony that came forward was absolutely amazing.

One professor who teaches university students came forward and said that 50% of individuals hospitalized in this country have an adverse reaction or there is a medical error before they are discharged. If those numbers are anywhere close to being true, we have a very serious problem on our hands and we have to deal with it.

I questioned those numbers, so I asked the next witness who came along and who I thought would have some information on this if he agreed with those numbers. In his testimony, the individual said that he could not refute those numbers, that they were probably very close to being accurate, if not underestimated.

We have a serious problem when it comes to this. We have to look at where we are as a nation. We are rated by the United Nations as the 30th best health care system in the world. The United States, by the way, is 37th, so we should not be looking to the United States for an example, but there are 30 nations that are better than we are. We had better start looking at what those 30 have to offer in giving us some information as to how we can deal with our health care system in a better way.

There are another 11 countries that have mandatory reporting of adverse reactions. The number one health care system in the world is France. France has mandatory reporting, but some people will probably get up and argue about whether it has really worked in France. It has not increased reporting that much more, but we can learn from them and understand how we can streamline the system to make it a lot easier for our professionals to be able to actually come forward to report the adverse reactions.

We have to look at what we can find out from these other countries in order to be able to dialogue with our professionals and to bring forward the actual piece of legislation and the way this has to be done, but we have to kick Health Canada in the backside to make sure it actually happens. That is what we have to do. It is absolutely important that every member of the House understands the opportunity before us: that on our watch, while we are here in the House, we have the opportunity to do something about it. We cannot delay. We absolutely have to vote for this motion so we can give the proper and appropriate direction to Health Canada.

This is long overdue and I encourage all members of the House to consider it. Saskatchewan put forward this kind of legislation in its province. We had to dialogue with the rest of the provinces to make this happen.

Topic:   Private Members' Business
Subtopic:   Adverse Drug Reactions
Permalink
LIB

John Harvard

Liberal

Hon. John Harvard (Parliamentary Secretary to the Minister of International Trade, Lib.)

Madam Speaker, I will be speaking to this motion in greater length in just a moment.

I appreciate the remarks made by the hon. member. Certainly, we on this side welcome the motion, but the question I have relates to his contention that a mandatory system would be better than a voluntary system.

I would like to hear him support that, that a mandatory system would be better than a voluntary system. As he already pointed out, France has a mandatory system, as does Italy and Sweden, but the information we have is that the reporting rates in those countries are really not significantly higher than elsewhere in the world where there are voluntary systems.

Could the hon. member provide some information in support of a mandatory system and why it would be better?

Topic:   Private Members' Business
Subtopic:   Adverse Drug Reactions
Permalink
CA

Rob Merrifield

Canadian Alliance

Mr. Rob Merrifield

Madam Speaker, I want to thank my hon. colleague for the question because it is a very valid one and something we really need to look at.

He is right in that other countries such as Italy, France and Sweden have the mandatory reporting. We also have to understand that they are rated one, two and three as far as health care systems in the world. There is no question that if we go down this road, it will give us the comfort zone of being a much better health care system.

Why are they not reporting numbers? We have to realize that in Canada we do have mandatory reporting for the pharmaceutical companies, but not for those on the frontlines who actually see it happen.

I should elaborate a little on some of the testimony we heard as we went across Canada. Those individuals who came forward with some of the numbers on adverse reactions said that our practitioners, our doctors and nurses, were not trained well enough to diagnose an adverse reaction when they saw it. We have to work on this in a multifaceted way. It is not that I think mandatory reporting will be the panacea and be the perfect solution. It is just one of the building blocks that we have to work on to get us to where we need to go so we can deal with this problem in a comprehensive way.

Part of the problem is that technology, the medical records following the patient and what that will allow us to do in this whole area of reporting has got to be exercised. We have to take a serious look at that. When we do, we have to engage the professional people, our pharmacists, nurses and doctors, and ask them how they can make this work in mandatory reporting.

This is not an attack. It is there to give them the tools to be better professionals. That is what this is all about. That is where we need to go. We should not do this in isolation with a big stick. We should do it in collaboration with the provinces and with the professionals to make it work. That is what Canadians expect and that is the way we should go.

Topic:   Private Members' Business
Subtopic:   Adverse Drug Reactions
Permalink
LIB

John Harvard

Liberal

Hon. John Harvard (Parliamentary Secretary to the Minister of International Trade, Lib.)

Madam Speaker, all Canadians want to know that the medicines they are taking are safe. They place tremendous confidence in the ability of Health Canada to effectively regulate the therapeutic product industry to enable access for them and their health care professionals to update product safety information.

To maintain and improve Canada's excellent drug safety record, Health Canada continues to be receptive to suggestions that increase our capacity to detect new problems with marketed drugs, and thereby reduce the potential for serious adverse reactions to drugs taken by Canadians.

The government welcomes the motion by the hon. member, which is something I have already said, that the government should consider making it mandatory for health care professionals to forward to Health Canada information on all serious adverse drug reactions within 48 hours of their occurrence. However, to potentially make a useful difference in drug safety, such a system should not only address the quantity of reports submitted but also the quality of the reports received.

At first glance, mandatory reporting might seem to be a useful approach to improved post-market drug safety. However, I would caution that it would be premature to draw this conclusion prior to a full and frank discussion with the provinces and territories and health profession groups on the issues that surround this matter.

Before discussing the many issues pertaining to mandatory adverse reaction reporting, let me give a background on the drug approval and post-market surveillance programs in Health Canada.

First, no drug is authorized for sale in our country before it has gone through clinical testing and a rigorous drug review process. Once a drug is on the market, Health Canada regulates the market authorization holder who is responsible to report known adverse reactions to Health Canada. Manufacturers also investigate complaints or reported problems, update conditions of drug use via changes to the product monograph, communicate new information to health professionals and consumers, and if necessary, limit the distribution of a drug or remove it from the market.

Health Canada itself also monitors adverse reactions as well as the effectiveness of the actions of manufacturers and can take regulatory action if necessary.

Patients, health professionals and manufacturers work together with the department to monitor adverse reactions. The Canadian reporting system consists of two components: mandatory reporting of serious side effects by manufacturers to Health Canada in accordance with our Food and Drug Act; and, the voluntary reporting of adverse drug reactions to Health Canada by health professionals. There are 23 countries worldwide, including the U.S.A., the United Kingdom and Australia which have similar combinations of mandatory and voluntary reporting systems.

Canada was also a founding member of the WHO drug monitoring program and continues to work with the WHO Uppsala Monitoring Centre with some 65 other member countries.

It is important to acknowledge that the effectiveness of all reporting systems are affected by reporting rates. Some international studies estimate reporting rates as low as 1% to 10%. The low rates can be attributed to barriers such as the lack of awareness about the existence and benefits of a report system, concerns about litigation and privacy, heavy workloads and confusion over when and what to report.

These barriers are a widely acknowledged international reality in the field of adverse reaction reporting. The schemes rely on a potential reporter making the connection between a symptom and a drug therapy and then taking the time to report. These are some of the challenges the department officials must face in their efforts to promote and encourage reporting.

It is also important to note that increasing the volume of reports by itself does not really lead to success. Our ability to identify potential and new safety problems also relies heavily on the contextual richness of the information in the case report describing the event and the circumstances.

Experts in pharmacovigilance responsible for post-market surveillance believe it is more effective to be making decisions based on fewer reports with high quality data than on many reports with poor quality data. An inherent challenge is to find a way to improve both reporting rates and the quality of the data submitted.

In addition to report promotional activities carried our by the network of five regional adverse reaction centres located in local drug information centres, a monthly Health Canada journal advertisement has been published in the Canadian Medical Association Journal to promote Health Canada's toll-free telephone and fax lines specifically established to facilitate adverse reaction reporting by health professionals.

Officials at Health Canada also actively participate at health professional meetings and conferences to promote the reporting program, improve its visibility and provide feedback to the health professional community as to how adverse reaction reporting contributes to the safe use of medications.

Another approach to stimulate reporting is targeting specialists. Health Canada has partnered with the Canadian Paediatric Society to launch an active surveillance initiative. The project will collect information from 2,300 pediatricians and subspecialists on a monthly basis.

The focus of reporting is on serious and life threatening adverse reactions in children and youth up to 18 years of age. In addition, the partnership will encourage pediatricians to report adverse drug reactions through regular reminders and monthly feedback to reporters.

Health Canada is also looking into ways in which mobile wireless technology, in other words palm pilots, can facilitate reporting.

We hope that this technology will enable health professionals to promptly and more completely report adverse reactions to Health Canada.

Health Canada also works with academia to encourage inclusion of education about adverse reaction reporting in curricula of health professional schools right across Canada. The department cannot, however, mandate the curriculum content of health professionals in Canada.

I would like to emphasize the importance of international information sharing. The size of the Canadian population is a key limiting factor in accumulating adverse reaction data in as short a time as in a larger population.

Rare, previously unidentified adverse reactions are only likely to be found when a drug is given to larger numbers of patients than took the drug prior to market authorization in clinical trials.

For this reason, Health Canada is collaborating with foreign regulators to use non-regulatory tools such as partnerships and information sharing, among other strategies, to counteract and overcome these limitations.

Over the past five years, Health Canada and the U.S. Food and Drug Administration, Australia's Therapeutic Goods Administration and New Zealand's MedSafe organization have worked closely in exchanging information on adverse drug reactions. In fact videoconferencing between them currently takes place on a bimonthly basis.

Drugs are used all around the world, and drug safety depends on countries working together and sharing information. It can be difficult for a relatively small country, like Canada, to accumulate sufficient domestic reports independently to evaluate signals for rare adverse reactions. That is why partnerships and cooperation are so vital.

Another improvement initiative currently in progress in the area of post-market surveillance would see Health Canada to move to the use of software developed for the U.S. FDA to manage Canadian adverse reaction reports.

All aspects of implementing mandatory reporting must be carefully weighed so that an informed decision can be taken on this issue.

If indeed mandatory reporting were to result in the generation of a higher number of quality reports, then it would certainly increase Health Canada's ability to determine drug safety problems.

It is true that reporting by health professionals is considered vital. However, at present Health Canada has no clear evidence that a mandatory reporting system would actually result in the increased submission of quality information.

Again, let me reiterate that, in principle, the government supports the motion as a means of potentially strengthening Health Canada's ability to generate drug safety signals. However, I must point out that there are still a number of aspects of this motion that require further clarification and discussion.

In closing, I know I can call on all the member of the House to support our future initiatives to improve the post-market surveillance activities of Health Canada.

Topic:   Private Members' Business
Subtopic:   Adverse Drug Reactions
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BQ

Paul Crête

Bloc Québécois

Mr. Paul Crête (Kamouraska—Rivière-du-Loup—Témiscouata—Les Basques, BQ)

Madam Speaker, first, I want to congratulate my colleague for his initiative. The good intention behind this motion is clear.

However, I am a bit surprised that this motion comes from a member of the official opposition, which for many years now, has sought less bureaucracy in the Canadian system. His motion states:

That, in the opinion of this House, the government should consider making it mandatory for health care professionals to forward to Health Canada information on all “serious” adverse drug reactions within 48 hours of their occurrence.

Clearly, in practice, this is designed to protect public health, to the hon. member's credit. However, we do not believe that Parliament should address this issue, because this is a provincial responsibility. Specifically, such a motion interferes with Quebec's responsibilities in health care.

I want to mention his choice of wording, because the motion talks about, “making it mandatory for health care professionals”. The federal government has no prerogative when it comes to health care professionals and cannot make anything mandatory for any of them. Health care professionals come under provincial jurisdiction and are regulated by the professional code.

It is therefore not relevant for the federal government to intervene in this matter. My government colleague indicated that it might be presumptuous to implement an additional system, when the provinces already have all the necessary structures in place. If such a system proves necessary, this should be done in collaboration with the provinces, through the sharing of certain information, instead of the imposition of an additional level of bureaucracy.

We believe that this motion seeks to protect public health by rapidly withdrawing dangerous drugs from the market, although it is impossible to know this. However, the motion mentions only the proposed action and not the intended goal. It would have been important to indicate that the drugs in question are patented drugs, for which approval by Health Canada is always required before they are marketed. It would also have been interesting to indicate that the purpose of this measure is to take a drug off the market as quickly as possible as a result of serious and unexpected side effects.

Getting back to the issue of bureaucracy, the enforcement of the proposed measure would involve costs, namely through the introduction of a cumbersome mechanism to be used by health care professionals, CLSCs and others, for informing Health Canada. We do not think this is the way to go. The use of this mechanism would also increase the workload for doctors and nurses who already have a lot on their plate.

Health care professionals always deal with the authorities in Quebec and the other provinces. It is a natural mechanism of cooperation. With this motion, a third party would be added, an intermediary who would have his own way of doing things. When the federal government becomes involved in this type of area of activity, it always tends to impose its methods directly on health care managers. This seems like a blatant and undesirable intrusion. Is the addition of an intermediary the answer? The Bloc Quebecois says not.

This is an encroachment upon the jurisdictions of Quebec and the provinces. This obligation on health care professionals would entail the introduction of a mechanism that would act in direct cooperation with Health Canada.

We in the Bloc Quebecois have always seen ourselves as the defenders of Quebec's and the provinces' jurisdiction over health. The federal role in health is to provide funding under funding redistribution agreements. It is not its role, however, to assume responsibility for the actual administration of the system. We did not take long to realize that the federal government does not dazzle with its performance in administering those sectors that are within its jurisdiction.

We are not, therefore, prepared to acquiesce to giving the federal level any greater role in the way health is administered. The Bloc Quebecois is therefore opposed to this motion.

Any direct intervention with health professionals in hospitals and CLSCs represents an intrusion into Quebec's jurisdiction. Quebec and the provinces could, if they wanted, create a system similar to the one proposed, but it is certainly not up to the federal government to demand anything whatsoever.

If the provinces together, through their health ministers, said that they ought to develop a system taking into account the procedures of each, plus an overall system to consolidate all of the data, that would be a path to take in future. But assigning that responsibility to the federal government, which would lead it subsequently to intervene with the provinces to start demanding that data be presented in a certain way, is unacceptable to us.

Presumably, physicians generally assume their responsibilities and are already informing the authorities when events such as those referred to in this motion occur.

If this is not the case, then there are professional bodies with responsibility for ensuring that things are done properly. In our opinion, however, the objective will not be attained by creating an additional bureaucracy.

The hon. member introduced this motion with every good intention, but I would say this to him: let us leave it up to Quebec and the provinces to judge the validity of such a proposal. But it is not up to the federal government to assume that responsibility.

I will therefore be opposing this motion when it is time to vote on it.

Topic:   Private Members' Business
Subtopic:   Adverse Drug Reactions
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NDP

Pat Martin

New Democratic Party

Mr. Pat Martin (Winnipeg Centre, NDP)

Madam Speaker, I am very pleased on behalf of the NDP to join in on the debate on the motion put forward by the member for Yellowhead. I thank him for recognizing that a very similar motion was put forward in the first session of the 37th Parliament by the NDP health critic, the member for Winnipeg North Centre.

We certainly share the hon. member's very real concern over this issue. We recognize that the motion tries to address a question of health of very real and timely pertinence to all Canadians. It seeks to ensure that the medications that people are required to take because of illness are in fact safe beyond a reasonable doubt.

The motion is very simple and very straightforward, as the best motions often are. It calls upon the government, in cooperation with the provincial and territorial governments I should add, to put in place a system of mandatory reporting of adverse drug reactions.

Many of us were shocked to learn in investigating this issue that it is estimated that approximately 10,000 people a year die of adverse drug reactions in Canada. I do not think any of us are naive enough to think that by putting this registry in place we would prevent all 10,000 deaths per year, but it is safe to say that we could prevent a significant number of them if we took proactive, concrete steps to introduce a systematic way of sharing the information on adverse reactions.

Like so many things, I think a lot of Canadians believe that such a system is already in place in Canada. Many would be surprised to learn what a disorderly system is currently in place.

I should back up for a second and point out that Health Canada started to keep track of adverse reactions of drugs in the 1960s. The database was set up after women who had been taking the drug thalidomide gave birth to babies with serious birth defects, as many of us of the right age will remember. Health officials worldwide had noticed the problem too late, tragically. They vowed collectively it would never happen again. A database was put together and was started in this country, but researchers have been having a difficult time finding out what is in that database, how it is structured and how that information is in fact used.

When we did finally get to the bottom of it in researching this database, we found that there are 162,000 records of Canadians who have had a bad reaction to prescription drugs. Data in and of itself is meaningless until it can be analyzed and shared and used. This stockpile of incidents is not satisfactory in terms of having a mandatory adverse reaction registry that can be shared and can be accessed by all doctors and pharmacists.

One of the things that really turned a lot of heads when this research was done was that the number of adverse reactions among Canadians has absolutely skyrocketed in recent years. Among children in the last five years the number of serious incidents has tripled. That in and of itself should motivate Parliament to take action.

Again, I compliment the member for Yellowhead for being the one to champion this issue in the House of Commons because I was shocked to learn that Health Canada obviously is missing some of these vital signals.

One of the reasons the rate of adverse reactions in children has tripled and is growing much more quickly than in adults is that often there is off-label use of the drugs and the drugs were never tested on children. They were not really designed and meant for children.

A ridiculous example is that Viagra is being given to children who have serious lung problems to open up the cardiovascular capacity in their lungs. It was never intended for that use.

Pediatricians are in fact using drugs, what is called off-label use of drugs, more and more and there have been serious incidents of adverse reactions. The number of incidents has tripled over the last five years. We need no other reasons frankly, but if that were the only reason to introduce the mandatory adverse reaction registry, it would be enough for me to hold up my hand to vote for its introduction right away.

For many of us the issue crystallized when we learned of the well-publicized death of a young girl in Oakville, Ontario, Vanessa Young. She was 15 years old. She died because the drug she was prescribed, Prepulsid, was prescribed for the wrong circumstances. By all accounts this was a preventable death. Her father, Terence Young, to whom we should pay tribute, has carried on a mission since his daughter's passing to ensure that we as a society learn a valuable lesson from Vanessa's death. Surely that should compel us to take action today; that father's suffering and that family's suffering for an unnecessary and preventable death of a young Canadian girl, what more reason do we need.

We certainly became much more aware of the problems associated with adverse drug reactions and the absence of any substantive policy in this area as a result of Vanessa's death. We owe it to her to ensure that her death was not in vain, that we learn lessons from this tragedy. We must ensure that people in similar circumstances are not affected by something that is so preventable, so easy to grasp and so relatively easy to implement, in fact. We are not looking at a huge cost factor, as the mover of the motion pointed out.

At that time, the member for Winnipeg North Centre, the NDP health critic, raised with the House of Commons that Health Canada had information that it could have shared and acted upon many months before the death of Vanessa Young, but it failed to do so. It was not compelled to do so. The information was housed in a warehouse of information with 162,000 incidents. It did not constitute a database; it constituted a pile of information, essentially. There was no easy way for pediatricians, family doctors or pharmacists to research recent experience with certain pharmaceutical products.

The point of today's debate is not to lay blame but to find solutions. As a result of Vanessa's death, there was a coroner's inquest. The jury made a number of recommendations. One was the mandatory reporting of adverse drug reactions within 48 hours of the incident taking place. That seems to be a very reasonable solution to a very serious problem and one for which there is no reason to delay and no reason to avoid action.

I was disappointed to hear the rather vapid approach by the parliamentary secretary on the government side who spoke to this issue. I honestly thought that we would hear a more enthusiastic approach. What would be wrong for the Liberal government to stand up and say to the member for Yellowhead that he is right, that we should do something about this? The Liberals would not lose any political points for admitting that this is a shortfall in our health care system. They would gain political points for leaving their political baggage at the door for once in their lives and for doing what was right for Canadians in this regard.

I welcome the opportunity to throw my enthusiastic support behind the member for Yellowhead on this initiative, and the support of the entire, massive NDP caucus, as many votes as we can muster. We will be voting in favour of this initiative.

It is a pleasure to end the week on a note of doing something that would be good for Canadians were this motion allowed to go through to its natural conclusion.

Topic:   Private Members' Business
Subtopic:   Adverse Drug Reactions
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CA

James Rajotte

Canadian Alliance

Mr. James Rajotte (Edmonton Southwest, CPC)

Madam Speaker, I want to take this opportunity to congratulate you on your new position.

I want to follow up on the comments by my colleague from the NDP who just spoke. Whenever the Conservatives and the NDP can agree on anything it must be a good thing for Canada.

I appreciate the opportunity to address the motion, which calls for the mandatory reporting of serious adverse drug reactions. I want to begin by saluting the intent of the motion, which is to raise awareness and increase reporting of such events so that Health Canada can act in a more timely manner.

Before I get into the details of the motion, I would like to pay tribute to the hon. member for Yellowhead, who is my colleague in the Conservative Party and our health critic. He has done an excellent job of raising awareness, certainly on these issues, but on many other issues in the health field. He is one of the hardest working members in the House and I salute him for putting this forward.

By way of background, I would like to explain what I mean by an adverse drug reaction. An adverse drug reaction is any unintended response to a drug, whether it is a prescription drug, a non-prescription drug, a biologically derived product, such as a vaccine, or a herbal product.

The food and drug regulations in Canada define an adverse drug reaction as a “noxious and unintended response to a drug which occurs at doses normally used or tested for the diagnosis, treatment or prevention of a disease or the modification of the modification of an organic function”.

Reactions may be evident within only minutes or may be delayed by years after Canadians initially use a product. Adverse reactions to drugs could be considered minor, such as a skin rash, but some very serious reactions have occurred, from heart attacks within days of drug use to long term liver damage.

According to Health Canada, 51% of drugs will cause some side effects. According to the CBC news on February 17, 2004--it has been doing a special, we should know, on this whole issue--the number of children in Canada harmed by suspected adverse prescription drug reactions has tripled in the last five years.

Even after 10 years on the market, new information on the public's adverse reaction to drugs can impact the use of a product.

For example, Merital, an anti-depressant that had been available in Germany since 1976, was approved in the U.S. in 1985. At the time of U.S. approval, the American food and drug administration was aware of less than 20 cases of anemia associated with the use of Merital. Hemolytic anemia is an anemia resulting from an increased rate of red cell destruction.

When the FDA began collecting data on the drug for domestic and foreign adverse drug reaction databases, it discovered that these anemias caused by Merital might be fatal. As a result of this research, the manufacturer announced the worldwide withdrawal of the drug a year later.

The exact motion before the House states:

That, in the opinion of this House, the government should considering making it mandatory for health care professionals to forward to Health Canada information on all “serious” adverse drug reactions within 48 hours of their occurrence.

I think that is important to know. I think the motion gets my Liberal colleague's support because it says that the government should consider. It is not exactly a directive but obviously the intent of the motion is to make it mandatory. However I think it should be broad enough to include members who possibly do have concerns about how this will be implemented. The fact that the motion is more general than a specific piece of legislation should also cause more members to support the motion.

The reporting of adverse drug reactions by both health care professionals and by individual Canadians is extremely important. The fact is that many Canadians are unaware of the adverse drug reaction database that currently exists. Part of this problem is because the reporting system is voluntary. National adverse reaction reporting activities are co-ordinated by the marketed health products directorate of Health Canada. Yet how many Canadians actually know that we have a marketed health products directorate in Health Canada? It would be interesting to actually know that.

That is why the motion is being introduced. It is why an editorial in the Globe and Mail today describes the reporting of adverse reactions to certain drugs as haphazard. There is no system in place that covers all these reactions.

While manufacturers are legally responsible to provide Health Canada with any important safety information for health products they sell in Canada, doctors, nurses and health care professionals are not required to make any reports.

The information gap that exists could be contributing to preventable illnesses and even deaths. Health Canada estimates that only 10% of adverse drug reactions are reported. If more physicians, pharmacists and ordinary Canadians reported reactions, it would certainly save the health care system money.

I want to address that issue, and I know the hon. member for Yellowhead has talked about this a number of times. The health care system should be moving forward. In Alberta they are moving forward with what is called a personal electronic health care record, which, hopefully, will improve the way in which health care services are delivered. It will also have the complementary effect of making Canadians more aware of their health care and the benefits they are receiving because it will allow personal records to follow with the patient. This will allow physicians and pharmacists to compare and contrast notes to ensure that the drugs their patients are receiving are complementary, that they are not receiving one drug that could have an adverse effect if taken with another drug that they have been prescribed.

I see the motion as working hand in hand with that type of a system of moving toward the personal electronic health care system.

Before I conclude I want to address the concerns of the member of the Bloc Quebecois who spoke about provincial jurisdiction. I think, quite frankly, that the motion does not interfere with provincial jurisdiction. One could, I am sure, get the consensus of all the provincial health ministers with this motion. This is essentially a motion to improve the reporting and look after the health and safety of Canadians, whether they are in Quebec or in any other province. We should not let this get caught up in a federal-provincial debate here.

I would like to emphasize that the intent of the motion is certainly beneficial and we in the Conservative Party will be supporting it, and we hope all parties will as well. It would be beneficial for all Canadians to be aware of this database and to use it more frequently, and that is why we think that making this mandatory would be a good step. The bottom line is that only good things can come from such a database if it does have more information, if there is a more systematic information system in place. Hopefully we can prevent some of the tragedies we have seen from adverse drug reactions.

Again, I encourage all my colleagues to support this excellent motion of my colleague, the member for Yellowhead.

Topic:   Private Members' Business
Subtopic:   Adverse Drug Reactions
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CA

Rob Merrifield

Canadian Alliance

Mr. Rob Merrifield

Madam Speaker, I listened intently to my colleagues as they deliberated and discussed the merits of this motion. All parties of the House, except the Bloc, are in favour it. The only opposition the Bloc has is that it deals with provincial jurisdiction. In recognizing that, this is not an attack against any province.

In fact, just as many of those hardworking and well-intended individuals in Quebec are dying because of adverse reactions as any place in Canada. If anything, this is something that the Bloc should be applauding because it would stimulate that province into facilitating this and ensuring that it happens within that province.

We have to gather the data somewhere and that is now happening in Health Canada. We should expand that to make it mandatory reporting. We have a database which is not interfering with provincial jurisdiction. It is working hand and glove. That is the way our health care system was designed originally and the way it should continue to be moving forward into the 21st century.

We should design a health care system that puts the patient first and then works in the best interests of the patient. All levels of government, provincial and federal, must work together to that end. That is indeed what we are trying to promote in this motion and why I would encourage the Bloc members to reconsider their support.

This is about sending a message of awareness to the country and Health Canada. This is something that absolutely must happen and must happen in a mandatory fashion.

Some of the things we should consider is why this is quite timely. In the Globe and Mail today, one of the editorials talks about pushing for mandatory reporting. The CBC has been discussing this all week long. This is more faith than anything else. It is sort of a lottery where this motion comes forward at a time when in a week there is such interest in the nation on this issue.

The program Disclosure last week had a half-hour documentary exposing the problem and considerations of why we should be doing it. There is no question that tens of thousands of individuals are passing away on a yearly basis in Canada on our watch because we are not doing anything about it. Would this save all of those individuals? No, but it is a stepping stone toward putting in place a system that would help. We need to consider and deliberate on what is actually happening.

I have spoken with the Canadian Medical Association this past week. It has always reneged with regard to support for the idea of mandatory reporting; however, it is not resisting like I had thought it would. I am meeting with the president next week and we will be discussing this and other issues, I am sure.

I look forward to that deliberation because this is not an attack against the professionals. This is an ability for us to work in collaboration with them in order to set up a system. We need to listen to them to hear their concerns and to understand how we can streamline this mandatory reporting in a way that will be palatable to them and to others.

I encourage all members of the House to consider this. I encourage them to talk to their colleagues who are not here, and to talk to their friends and families because if they do not know of someone who has been affected by an adverse reaction, those other people do. This is an important issue. The health and welfare of Canadians is hanging in the balance and, on our watch, we should do something to solve it.

Topic:   Private Members' Business
Subtopic:   Adverse Drug Reactions
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?

The Acting Speaker (Mrs. Hinton)

Is the House ready for the question?

Topic:   Private Members' Business
Subtopic:   Adverse Drug Reactions
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?

Some hon. members

Question.

Topic:   Private Members' Business
Subtopic:   Adverse Drug Reactions
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?

The Acting Speaker (Mrs. Hinton)

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

Topic:   Private Members' Business
Subtopic:   Adverse Drug Reactions
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?

Some hon. members

Agreed.

Topic:   Private Members' Business
Subtopic:   Adverse Drug Reactions
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?

Some hon. members

No.

Topic:   Private Members' Business
Subtopic:   Adverse Drug Reactions
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?

The Acting Speaker (Mrs. Hinton)

All those in favour of the motion will please say yea.

Topic:   Private Members' Business
Subtopic:   Adverse Drug Reactions
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?

Some hon. members

Yea.

Topic:   Private Members' Business
Subtopic:   Adverse Drug Reactions
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?

The Acting Speaker (Mrs. Hinton)

All those opposed will please say nay.

Topic:   Private Members' Business
Subtopic:   Adverse Drug Reactions
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?

Some hon. members

Nay.

Topic:   Private Members' Business
Subtopic:   Adverse Drug Reactions
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February 20, 2004