Health Committee on April 29th, 2008

[Robert Thibault, Liberal, West Nova, NS]

With Bill C-51, with the progressive licensing, do you see an opportunity to improve the off-label situation? I don't want to stop off-label use. I understand that it's a necessity, but it seems that it has become almost systematic—most of the new pharmaceutical products used for children haven't been tested for children. They all end up being off-label, and you wonder if the proper information is getting around. Do you see some possibilities for improvement?

[Tom Brogan]

Yes, there could be dramatic improvement in monitoring off-label use. The administrative data can lead you to some pretty sound conclusions, which need follow-up.

[Robert Thibault, Liberal, West Nova, NS]

Beyond the monitoring, you'd have to impose some clinical trials on that population.

[Tom Brogan]

That's right. One option is to look at what's been done in other countries. Have Health Canada negotiate with the drug companies to encourage them to do trials in children. I believe in the U.S.—it's been a while since I've studied their law—that for pediatric use a company will get a certain period of market exclusivity if they conduct the research for that use in children. So there are incentives available.

[Robert Thibault, Liberal, West Nova, NS]

We've heard from witnesses that only about 10% of serious adverse events get reported. We've seen the actual incidence of events in the population. In your study on pediatric pharmaceutical use, are the negative adverse events higher?

[Tom Brogan]

We didn't measure adverse events.

[The Chair, Conservative, Joy Smith]

Monsieur Malo.

[Luc Malo, Bloc, Verchères—Les Patriotes, QC]

Thank you, Madam Chair.

Ladies and gentlemen, thank you for being here with us.

Mr. Ménard, in your presentation, you said that there should be a legal framework for everything related to pharmaceutical vigilance. More specifically, how should this be done?

[Jean-Pierre Ménard]

First, the main principles of the legislation and details can be specified in the regulations. However, the legislation should be amended to include the possibility, even the duty, for everyone to act—depending on whether we want to make it an obligation for certain groups within the population such as health care professionals or others—and set out in the regulations a formal mechanism in order to report all adverse effects. We should also create a mechanism for the government to receive such information and assess its merits, so that individuals reporting such cases can get input and we can be certain that all these reports are being put to good use.

Currently, it is possible to know whether a certain number of cases regarding a particular medication have been reported and the effects, but is this a reality? Scientifically, is there a recognized link between the drug and the complication? How important is it? At present, there's nothing to validate the results or follow up on reported cases in a structured way. I think it would be useful to have a structure or an organization—a little bit like the risk-management committees mandated under Quebec law—to study this and to make recommendations or to provide a follow-up to these questions.

It would also be appropriate to consider the possibility of simplifying the administrative process, for example, with the assistance of the health care system. People have been designated for these purposes. Some people have difficulty reporting problems. In the case of seniors who have difficulty reading and writing or who suffer from adverse reactions to drugs, it can be extremely difficult to get them to report this via the web.

So, I think that we need mechanisms or processes in the health care system to help people do these kinds of things too. This should be done through the health care system, because it's more difficult for people to deal directly with Health Canada. People don't know where to begin to do this.

[Luc Malo, Bloc, Verchères—Les Patriotes, QC]

You say that you have no opinion on whether or not these reports should be mandatory or voluntary?

[Jean-Pierre Ménard]

The issue of mandatory reporting is something that could be discussed at great length. In the Quebec legislation, there are a number of procedures that relate to mandatory reporting. For example, any accidents that occur with vaccines must be reported. There is also widespread under-reporting. It is estimated that only 5, 6 or 7% of cases are reported.

The problem surrounding any implementation of a mandatory reporting process relates to the sanctions that will apply if reporting does not occur. The College of Physicians refuses to apply any type of penalty. Therefore, I think that the provinces and the professional bodies should take a close look at this issue. It is a matter of educating the professionals.

Moreover, having it included in the act makes it a tool, an instrument that cannot be overlooked. We must not say that since people are ignoring the requirement, it should not be included. I don't think it would be useless to include it, because it could eventually be used for education, training, planning of programs and procedures. We are only seeing the very tip of the iceberg, when it comes to the number of reports that are being made at this time. I have a feeling that in the field, this is something that is more apparent because the pharmaceutical component represents an important aspect of our practice. Drug-related accidents are constant and frequent. This is also an important part of our professional practice.

It has become quite clear that there is not enough public monitoring taking place at this time. Very little is known about the effectiveness of this monitoring. What we do have is limited to informal checks. It is clear that we will have to strengthen that side of the equation as well.

[Luc Malo, Bloc, Verchères—Les Patriotes, QC]

Madam Chair, if I may, I would like to give the rest of my time to my colleague Ms. Gagnon.

[The Chair, Conservative, Joy Smith]

Absolutely.

You have about two minutes, Madame Gagnon.

[Christiane Gagnon, Bloc, Québec, QC]

I will be very brief, Madam Chair.

I would like to come back to a drug, the Gardasil vaccine, which was linked to the death of young girls in other countries. There were apparently 11 deaths. When a drug is taken off the market, under what circumstances—and I know that you are a legal professional and that you provide help in similar cases—there be agreement to continue the vaccination campaign? We know that Quebec has started an intensive campaign to vaccinate adolescent girls, even though some people have died elsewhere. What is the relationship between the drug and the cause of the illness?

[Jean-Pierre Ménard]

With respect to public authorities, the main concern is the safety of the population with regard to this type of occurrence. In general, if information leads one to believe that a product might be dangerous, I think that it is within the powers of the public authorities to immediately stop vaccinating people. Quebec law currently allows for an immediate stop to any vaccination program, for example. However, the power to withdraw a drug from the market rests with the federal government. The law also provides for other types of authority. In my opinion, it depends upon the will or lack of will to exercise these powers. From my understanding of the law, I will say that the current powers are adequate. But do we or do we not want to use them? It is a matter that relates more closely to politics than it does to law.

[The Chair, Conservative, Joy Smith]

Is that the end of your questioning, Madame Gagnon?

[Christiane Gagnon, Bloc, Québec, QC]

Not enough care was taken with respect to Gardasil, because the vaccination campaign is continuing. Quebec started vaccinating two or three weeks ago. You are a legal expert, can you tell us who would be responsible if a young girl in Quebec were to die after being vaccinated with Gardasil?

[Jean-Pierre Ménard]

Vaccinations come under public health, and the federal government is also involved in that area. There is a very high degree of vigilance regarding all those problems.

[Christiane Gagnon, Bloc, Québec, QC]

What is their legal responsibility?

[Jean-Pierre Ménard]

If we are told about a risk or a known association and if the government or the institution that carried out the vaccination does not report it, there is clearly a responsibility. The government is also accountable. It could be taken to court in such a case. We would obviously look into all those issues.

[The Chair, Conservative, Joy Smith]

Thank you very much.

[Christiane Gagnon, Bloc, Québec, QC]

Thank you.

[The Chair, Conservative, Joy Smith]

We now have Mrs. Wasylycia-Leis.

[Judy Wasylycia-Leis, NDP, Winnipeg North, MB]

Thank you.

Mr. Ménard, you said that if a provision was introduced into our legislation concerning mandatory reporting—

[Jean-Pierre Ménard]

Yes, mandatory reporting.