Health committee  I will send Mrs. Gagnon a copy of my notes.

Health committee  I apologize not to have brought....

Health committee  Currently, the obligation is contained in the regulations. We do not know how it is verified or applied by the government. It is in section 16 of the regulations.

Health committee  Obviously, I believe that these types of agreements are needed. In other countries, there are a certain number of agreements that acknowledge drug certification, for instance. Certain processes are approved in Australia, Japan, and countries of the European Union, for example. It is clear that with respect to regulation, we could very well assess what is being done with respect to some of the activities of pharmaceutical companies in the European Union, Japan, Australia and the United States.

Health committee  I believe that quantity is just as important. With respect to reporting adverse drug reactions, we could opt for a highly elaborate formula that only a professional would be able to understand easily, but it would be preferable to adopt a rather simple process. If we are serious about prevention, we absolutely need a critical mass.

Health committee  We did not identify any countries where adverse reactions were reported 100% of the time. The number of reports varies according to country, but rates never reach 90% or 95%. Rates are always lower. There are two schools of thought. Some say that even if we make reports mandatory, if there are no sanctions or consequences, this will mean that nothing will happen and people will not comply.

Health committee  I believe that a public message can be sent through making such reports mandatory.

Health committee  Firstly, there are laws that oblige doctors to indicate other things. For example, we have a law on youth protection, as well as a law on mandatory reporting. In Quebec, under the Health and Social Services Act, there's an obligation to declare all accidents or incidents. They are broader, but they are obligations nonetheless.

Health committee  Yes. There's a package insert with each drug. It contains a description of the drug, specifies the risks involved, and provides certain indications. It is clear that under the statute and regulations, the manufacturer should be obliged to indicate to the user where to report any adverse effect.

Health committee  I think it must be reported to public authorities. Currently, under-reporting is said to be prevalent. The problem regarding post-market regulation is that expectations concerning self-regulation by pharmaceutical companies are much too high. Yet, through experience, we know that this mechanism works to a certain extent, but is very limited.

Health committee  There are two issues that are significant. The notion of the right to medical safety is beginning to surface in all western health care systems. Ten years ago, this issue wasn't even discussed. We've only begun to talk about this in recent years, and it is becoming a major concern for the French, English, European and Canadian health care systems.

Health committee  Yes, mandatory reporting.

Health committee  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.

Health committee  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.

Health committee  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.