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.