Our industry is very clearly regulated as to our responsibility with respect to developing the appropriate labelling that describes the risk-benefit profile of the drug when it goes to market.
As you know, once the drug reaches the market, obviously there could be the occurrence of rare events, which could be serious, so there is an evolution of the labelling based on this post-marketing surveillance. The safety of a product is subject to scientific scrutiny. I believe that good science should be open and there should be checks and balances. I do not believe that safety can be in a repository in isolation, without the manufacturer, the clinical experts, the regulatory agencies, and academia. Science has to be a public forum for challenge and scrutiny. When you refer to the post-marketing diligence program that Health Canada is following now, especially with the last draft guidance that was issued last month, we see that they encourage, or they are favourable to, the use of standards that have been developed through ICH, such as E2E.