Health committee  It is very clearly. When we talk about life-cycle management, that really does get to the crux of following the drug, both from a safety point of view and also a benefit point of view. We start monitoring right from the first introduction in human beings, so the first phases of clinical trial we're starting to already plan out how we will construct vigilance.

Health committee  We're learning from the U.S. proposals. Functionally, within Health Canada, we also get the benefit of a lot of the tools that have been constructed by the U.S., for example, the REMS—so the plans going out into market to follow vigilance. We do get those filed. We also get them filed from Europe.

Health committee  Thank you, Madam Chair. Orphanet aggregates a lot of information about rare diseases. So it will list disease states, patient organizations associated with them, and trials going on. Medical professionals can use it; patients can use it. It's typical that, if you are starting up a study, for example, on a particular rare disease or you've identified something new genetically, then you would enter that information into that world database.

Health committee  Thank you, Madam Chair. In terms of safety, that's a very, very important aspect of the new rare disease framework. Recognizing that the food and drug regulations themselves are somewhat older, we do have powers on market tracing and finding out what's going in the market, largely through the reporting of adverse drug reactions.

Health committee  Thank you, Madam Chair. On October 3, 2012, the Minister of Health announced the development of a modern framework for orphan drugs. These are drugs used to treat rare diseases. This opens the way for increased Canadian research and development of these drugs and for improving Canadian patient access to treatment.

Finance committee  This is a precise characterization. There is no exemption in terms of what we do on the scientific basis. So as we look at things like food additives, important anti-microbials, or on schedule F, the same science is conducted, and then the rule is expressed much more rapidly and efficiently.

Finance committee  It was much earlier than that, recognizing that what we're changing is a very old regulatory structure. Some of it is about 50 years old, and possibly older. There have been pressures on the time it takes, following scientific review, to just reflect a regulatory amendment.

Finance committee  This is quite narrow—it speaks only to the regulation-making process conducted by others.

Finance committee  That's correct.

Finance committee  We're quite satisfied that there would be no change in the protection elements of this. The expression in a regulatory table.... If you look at the food and drug regulations, it's a very thick piece—

Finance committee  Yes, of course. It's a very thick document and it's full of tables that you will look at. Those tables will look the same in the administrative list. The administrative list will also have the same force of law. So if you're looking at the website, you will see no material difference in those that have to follow those rules, and again, the science in behind it is exactly the same.

Finance committee  That is completely correct.

Finance committee  We would not characterize it in that way. The minister is doing the same scientific process as always. There is no exemption from a compound either on the drug side or the food side going through the same scientific rigour. All that is changing is how that is expressed, and in fact it just goes on a list that's again incorporated by law, has the force of law, but it doesn't go through a whole regulatory amendment.

Finance committee  No, this instrument does not give the minister that ability. In fact, there was an interim marketing authorization set of provisions that was introduced earlier into the Food and Drugs Act with the same aim, to make it more efficient, but those sunsetted after two years. Looking back, they did not get us to the efficiency we were looking for.

Finance committee  Correct.