International Trade committee  There are a number of clauses in there. First of all, there is the one about patent term extension. Currently, patents are valid for 20 years from the date of filing. The TPP doesn't give a number, it would probably add two years of patent life, which means that would delay generic drugs coming on the market for two years.

International Trade committee  Sure.

International Trade committee  I am going to talk only about pharmaceutical issues. From that perspective, the TPP is going to have potential negative effects—we really won't know until the disputes start and we see how it is going to be interpreted—on both prices and regulations. For instance, a colleague and I did calculations on the effects of CETA, the Comprehensive Economic and Trade Agreement with the European Union.

International Trade committee  Which one?

International Trade committee  This kind of thing is being debated heavily in the United States, in Australia, and in New Zealand, so yes, sure.

International Trade committee  They might disagree. They'd be wrong, but....

International Trade committee  Thank you very much. My name is Joel Lexchin. I teach health policy at York University, and I work at the University Health Network as an emergency physician. I'm going to comment about the possible implications of the TPP on drug regulation and prices. There are five separate chapters or annexes that could potentially affect these areas.

Health committee  I suppose what I've seen that's most likely to lead to patient harm is the inappropriate use of antibiotics for viral conditions or where there's no infection in the first place, or where the wrong antibiotics have been chosen and that leads to cases of C. difficile. C. difficile, especially in the elderly, can be very difficult to treat and can require prolonged hospitalizations, or as your colleague said, can lead to death.

Health committee  I definitely do. For instance, if we have evidence of widespread off-label use of drugs, Bill C-17 would then allow the minister to require companies to undertake additional studies so we can gain better information about whether or not that off-label prescribing is or is not appropriate.

Health committee  We will never get to the point where there's absolute safety. That doesn't exist. But certainly the estimates are that somewhere around 60% of adverse drug reactions can be prevented, and one of the ways of preventing those is by having better information about when they occur and who they occur in.

Health committee  I think that Professor Herder outlined some of the steps that Health Canada or Canada has already taken in terms of data protection to try to ensure that the information is not used for unfair commercial purposes. In terms of the full results of the clinical trials that have been undertaken, we could initially look at what I described with respect to the model that GlaxoSmithKline has committed to, which is that they will release all of the data on critical trials once researchers have made an application and that application has been vetted by an independent committee so that you get this information out there to the people who will be able to use it.

Health committee  I've read a little bit about that, but I wouldn't be able to comment on—

Health committee  Definitely, yes.

Health committee  Yes. I think that we need better sources of data than we currently have. For instance, in most provinces there is no single source where you can find out prescriptions that have been dispensed. British Columbia is an exception. Their PharmaNet program records every prescription that has been dispensed, regardless of who has been paying for it.

Health committee  No. For any new prescription or in fact non-prescription drug to reach the market, Health Canada has to evaluate the information that the companies submit about those drugs. The problem is that the trials that are done before a drug is on the market are relatively restricted kinds of trials.