First and foremost, the assumption is that one receives quality data. Typically when a case is received by a drug safety associate who is a health care professional by background, the quality of the data received is peer-reviewed, medically reviewed, and management reviewed, and then submitted as per the regulatory timelines, either 7 or 15 days for the serious expeditable or in the periodic report format that my colleague, Dr. Fontana, alluded to.
Before we can make any public communication, we invariably end up in a discussion with the regulator, no matter what jurisdiction we're in, to agree on the format of the communication and the quality of the signal or the issue we have seen. As recently as December 2007, Health Canada signed a data exchange agreement with the EMEA. They do sit in on monthly calls, so it's their forum to share information with the other regulators. This is where we don't want to clutter the system, as Dr. Fontana alluded to, with duplicate reports going in, because you falsely attribute things, which is the very point I think you were trying to make.